Systems and methods for restoring muscle function to the lumbar spine and kits for implanting the same

ABSTRACT

A system for restoring muscle function to the lumbar spine to treat low back pain is provided. The system may include one or more electrode leads coupled to an implantable pulse generator (IPG) and a tunneler system for subcutaneously implanting a proximal portion of the lead(s). The system may also include a handheld activator configured to transfer a stimulation command to the IPG, and an external programmer configured to transfer programming data to the IPG. The stimulation command directs the programmable controller to stimulate the tissue in accordance with the programming data. The system may include a software-based programming system run on a computer such that the treating physician may program and adjust stimulation parameters.

I. CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/948,945, filed Apr. 9, 2018, now U.S. Pat. No. 10,449,355, which is acontinuation of U.S. patent application Ser. No. 15/202,435, filed Jul.5, 2016, now U.S. Pat. No. 9,950,159, which is a continuation-in-partapplication of U.S. patent application Ser. No. 14/792,430, filed Jul.6, 2015, now U.S. Pat. No. 9,474,906, which is a continuation of U.S.patent application Ser. No. 14/061,614, filed Oct. 23, 2013, now U.S.Pat. No. 9,072,897, the entire contents of each of which areincorporated herein by reference.

U.S. patent application Ser. No. 15/948,945, filed Apr. 9, 2018, nowU.S. Pat. No. 10,449,355, is also a continuation-in-part of U.S. patentapplication Ser. No. 13/797,100, filed Mar. 12, 2013, which claims thebenefit of U.S. Provisional Patent Application Ser. No. 61/659,334,filed Jun. 13, 2012, the entire contents of each of which areincorporated herein by reference.

II. FIELD OF THE INVENTION

This application generally relates to systems and methods forneuromuscular electrical stimulation, including stimulation of tissueassociated with control of the lumbar spine for treatment of back pain.

III. BACKGROUND OF THE INVENTION

The human back is a complicated structure including bones, muscles,ligaments, tendons, nerves and other structures. The spinal column hasinterleaved vertebral bodies and intervertebral discs, and permitsmotion in several planes including flexion-extension, lateral bending,axial rotation, longitudinal axial distraction-compression,anterior-posterior sagittal translation, and left-right horizontaltranslation. The spine provides connection points for a complexcollection of muscles that are subject to both voluntary and involuntarycontrol.

Back pain in the lower or lumbar region of the back is common. In manycases, the cause of back pain is unknown. It is believed that some casesof back pain are caused by abnormal mechanics of the spinal column.Degenerative changes, injury of the ligaments, acute trauma, orrepetitive microtrauma may lead to back pain via inflammation,biochemical and nutritional changes, immunological factors, changes inthe structure or material of the endplates or discs, and pathology ofneural structures.

The spinal stabilization system may be conceptualized to include threesubsystems: 1) the spinal column, which provides intrinsic mechanicalstability; 2) the spinal muscles, which surround the spinal column andprovide dynamic stability; and 3) the neuromotor control unit, whichevaluates and determines requirements for stability via a coordinatedmuscle response. In patients with a functional stabilization system,these three subsystems work together to provide mechanical stability. Itis applicant's realization that low back pain results from dysfunctionof these subsystems.

The spinal column consists of vertebrae and ligaments, e.g. spinalligaments, disc annulus, and facet capsules. There has been an abundanceof in-vitro work in explanted cadaver spines and models evaluating therelative contribution of various spinal column structures to stability,and how compromise of a specific column structure will lead to changesin the range of motion of spinal motion segments.

The spinal column also has a transducer function, to generate signalsdescribing spinal posture, motions, and loads via mechanoreceptorspresent in the ligaments, facet capsules, disc annulus, and otherconnective tissues. These mechanoreceptors provide information to theneuromuscular control unit, which generates muscle response patterns toactivate and coordinate the spinal muscles to provide muscle mechanicalstability. Ligament injury, fatigue, and viscoelastic creep may corruptsignal transduction. If spinal column structure is compromised, due toinjury, degeneration, or viscoelastic creep, then muscular stabilitymust be increased to compensate and maintain stability.

Muscles provide mechanical stability to the spinal column. This isapparent by viewing cross section images of the spine, as the total areaof the cross sections of the muscles surrounding the spinal column islarger than the spinal column itself. Additionally, the muscles havemuch larger lever arms than those of the intervertebral disc andligaments.

Under normal circumstances, the mechanoreceptors exchange signals withthe neuromuscular control unit for interpretation and action. Theneuromuscular control unit produces a muscle response pattern based uponseveral factors, including the need for spinal stability, posturalcontrol, balance, and stress reduction on various spinal components.

It is believed that in some patients with back pain, the spinalstabilization system is dysfunctional. With soft tissue injury,mechanoreceptors may produce corrupted signals about vertebral position,motion, or loads, leading to an inappropriate muscle response. Inaddition, muscles themselves may be injured, fatigued, atrophied, orlose their strength, thus aggravating dysfunction of the spinalstabilization system. Conversely, muscles can disrupt the spinalstabilization system by going into spasm, contracting when they shouldremain inactive, or contracting out of sequence with other muscles. Asmuscles participate in the feedback loop via mechanoreceptors in theform of muscle spindles and golgi tendon organs, muscle dysfunction mayfurther compromise normal muscle activation patterns via the feedbackloops.

Trunk muscles may be categorized into local and global muscles. Thelocal muscle system includes deep muscles, and portions of some musclesthat have their origin or insertion on the vertebrae. These localmuscles control the stiffness and intervertebral relationship of thespinal segments. They provide an efficient mechanism to fine-tune thecontrol of intervertebral motion. The lumbar multifidus, with itsvertebra-to-vertebra attachments is an example of a muscle of the localsystem. Another example is the transverse abdominus, with its directattachments to the lumbar vertebrae through the thoracolumbar fascia.

The multifidus is the largest and most medial of the lumbar backmuscles. It has a repeating series of fascicles which stem from thelaminae and spinous processes of the vertebrae, and exhibit a constantpattern of attachments caudally. These fascicles are arranged in fiveoverlapping groups such that each of the five lumbar vertebrae givesrise to one of these groups. At each segmental level, a fascicle arisesfrom the base and caudolateral edge of the spinous process, and severalfascicles arise, by way of a common tendon, from the caudal tip of thespinous process. Although confluent with one another at their origin,the fascicles in each group diverge caudally to assume separateattachments to the mamillary processes, the iliac crest, and the sacrum.Some of the deep fibers of the fascicles that attach to the mamillaryprocesses attach to the capsules of the facet joints next to themamillary processes. The fascicles arriving from the spinous process ofa given vertebra are innervated by the medial branch of the dorsal ramusthat issues from below that vertebra. The dorsal ramus is part of spinalnerve roots formed by the union of dorsal root fibers distal to thedorsal root ganglion and ventral root fibers.

The global muscle system encompasses the large, superficial muscles ofthe trunk that cross multiple motion segments, and do not have directattachment to the vertebrae. These muscles are the torque generators forspinal motion, and control spinal orientation, balance the externalloads applied to the trunk, and transfer load from the thorax to thepelvis. Global muscles include the oblique internus abdominus, theobliquus externus abdmonimus, the rectus abdominus, the lateral fibersof the quadratus lumborum, and portions of the erector spinae.

Normally, load transmission is painless. Over time, dysfunction of thespinal stabilization system is believed to lead to instability,resulting in overloading of structures when the spine moves beyond itsneutral zone. The neutral zone is a range of intervertebral motion,measured from a neutral position, within which the spinal motion isproduced with a minimal internal resistance. High loads can lead toinflammation, disc degeneration, facet joint degeneration, and musclefatigue. Since the endplates and annulus have a rich nerve supply, it isbelieved that abnormally high loads may be a cause of pain. Loadtransmission to the facets also may change with degenerative discdisease, leading to facet arthritis and facet pain.

For patients believed to have back pain due to instability, cliniciansoffer treatments intended to reduce intervertebral motion. Commonmethods of attempting to improve muscle strength and control includecore abdominal exercises, use of a stability ball, and Pilates. Spinalfusion is the standard surgical treatment for chronic back pain.Following fusion, motion is reduced across the vertebral motion segment.Dynamic stabilization implants are intended to reduce abnormal motionand load transmission of a spinal motion segment, without fusion.Categories of dynamic stabilizers include interspinous process devices,interspinous ligament devices, and pedicle screw-based structures. Totaldisc replacement and artificial nucleus prostheses also aim to improvespine stability and load transmission while preserving motion.

There are a number of problems associated with current implants that aimto restore spine stabilization. First, it is difficult to achieveuniform load sharing during the entire range of motion if the locationof the optimum instant axis of rotation is not close to that of themotion segment during the entire range of motion. Second, cyclic loadingof dynamic stabilization implants may cause fatigue failure of theimplant, or the implant-bone junction, e.g. screw loosening. Third,implantation of these systems requires surgery, which may cause new painfrom adhesions, or neuroma formation. Moreover, surgery typicallyinvolves cutting or stripping ligaments, capsules, muscles, and nerveloops, which may interfere with the spinal stabilization system.

Functional electrical stimulation (FES) is the application of electricalstimulation to cause muscle contraction to re-animate limbs followingdamage to the nervous system such as with stroke or spine injury. FEShas been the subject of much prior art and scientific publications. InFES, the goal generally is to bypass the damaged nervous system andprovide electrical stimulation to nerves or muscles directly whichsimulates the action of the nervous system. One lofty goal of FES is toenable paralyzed people to walk again, and that requires the coordinatedaction of several muscles activating several joints. The challenges ofFES relate to graduation of force generated by the stimulated muscles,and the control system for each muscle as well as the system as a wholeto produce the desired action such as standing and walking.

With normal physiology, sensors in the muscle, ligaments, tendons andother anatomical structures provide information such as the force amuscle is exerting or the position of a joint, and that information maybe used in the normal physiological control system for limb position andmuscle force. This sense is referred to as proprioception. In patientswith spinal cord injury, the sensory nervous system is usually damagedas well as the motor system, and thus the afflicted person losesproprioception of what the muscle and limbs are doing. FES systems oftenseek to reproduce or simulate the damaged proprioceptive system withother sensors attached to a joint or muscle.

For example, in U.S. Pat. No. 6,839,594 to Cohen, a plurality ofelectrodes are used to activate selected groups of axons in a motornerve supplying a skeletal muscle in a spinal cord patient (therebyachieving graduated control of muscle force) and one or more sensorssuch as an accelerometer are used to sense the position of limbs alongwith electrodes attached to muscles to generate an electromyogram (EMG)signal indicative of muscle activity. In another example, U.S. Pat. No.6,119,516 to Hock, describes a biofeedback system, optionally includinga piezoelectric element, which measures the motions of joints in thebody. Similarly a piezoelectric crystal may be used as a muscle activitysensor as described by U.S. Pat. No. 5,069,680 to Grandjean.

FES has also been used to treat spasticity, characterized by continuousincreased muscle tone, involuntary muscle contractions, and alteredspinal reflexes which leads to muscle tightness, awkward movements, andis often accompanied by muscle weakness. Spasticity results from manycauses including cerebral palsy, spinal cord injury, trauma, andneurodegenerative diseases. U.S. Pat. No. 7,324,853 to Ayal describesapparatus and method for electrically stimulating nerves that supplymuscles to modify the muscle contractions that lead to spasticity. Theapparatus includes a control system configured to analyze electricalactivity of one or more muscles, limb motion and position, andmechanical strain in an anatomical structure.

Neuromuscular Electrical Stimulation (NMES) is a subset of the generalfield of electrical stimulation for muscle contraction, as it isgenerally applied to nerves and muscles which are anatomically intact,but malfunctioning in a different way. NMES may be delivered via anexternal system or, in some applications, via an implanted system.

NMES via externally applied skin electrodes has been used torehabilitate skeletal muscles after injury or surgery in the associatedjoint. This approach is commonly used to aid in the rehabilitation ofthe quadriceps muscle of the leg after knee surgery. Electricalstimulation is known to not only improve the strength and endurance ofthe muscle, but also to restore malfunctioning motor control to amuscle. See, e.g., Gondin et al., “Electromyostimulation TrainingEffects on Neural Drive and Muscle Architecture”, Medicine & Science inSports & Exercise 37, No. 8, pp. 1291-99 (August 2005).

An implanted NMES system has been used to treat incontinence bystimulating nerves that supply the urinary or anal sphincter muscles.For example, U.S. Pat. No. 5,199,430 to Fang describes implantableelectronic apparatus for assisting the urinary sphincter to relax.

The goals and challenges of rehabilitation of anatomically intact (i.e.,non-pathological) neuromuscular systems are fundamentally different fromthe goals and challenges of FES for treating spinal injury patients orpeople suffering from spasticity. In muscle rehabilitation, the primarygoal is to restore normal functioning of the anatomically intactneuromuscular system, whereas in spinal injury and spasticity, theprimary goal is to simulate normal activity of a pathologically damagedneuromuscular system.

It would therefore be desirable to provide an apparatus and method torehabilitate muscle associated with control of the lumbar spine to treatback pain.

It further would be desirable to provide an apparatus and method torestore muscle function of local segmental muscles associated with thelumbar spine stabilization system.

IV. SUMMARY OF THE INVENTION

The present invention overcomes the drawbacks of previously-knownsystems by providing systems and methods for restoring muscle functionto the lumbar spine to treat, for example, low back pain. In accordancewith one aspect of the present invention a kit for use in restoringmuscle function of the lumbar spine is provided. The kit may include anelectrode lead having one or more electrodes disposed thereon, animplantable pulse generator (IPG), and a tunneler system configured tosubcutaneously tunnel between an incision site for implantation of thedistal end of the lead and an incision site for the IPG such that theproximal end of the lead may be coupled to the IPG for full implantationof the lead and IPG. The one or more electrodes may be implanted in oradjacent to tissue associated with control of the lumbar spine, e.g., anervous tissue, a muscle, a ligament, or a joint capsule, and may becoupled to the IPG via the electrode lead to provide electricalstimulation to the target tissue. The tunneler system may includetunneler, a sheath, and a tunneler tip. The tunneler may have a handleon the proximal end and may be removably coupled to the tunneler tip ata distal portion of the tunnel for creating a subcutaneous passage. Thetunneler tip may be bullet-shaped or facet-shaped. The sheath may bepositioned over the tunneler between the handle and the tunneler tipsuch that the sheath may be disposed temporarily in the subcutaneouspassage to permit the proximal portion of the lead to be fed through thesheath to the IPG for coupling to the IPG.

The IPG may include a first communications circuit, and the kit may alsoinclude a handheld activator having a second communications circuit andan external programmer having a third communications circuit. Theactivator may transfer a stimulation command to the IPG via the firstand second communications circuits, and the external programmer maytransfer programming data to the IPG via the first and thirdcommunications circuits, such that the stimulation command directs theprogrammable controller to provide electrical stimulation in accordancewith the programming data.

The programmable controller may direct one or more electrodes tostimulate target tissue, e.g., a dorsal ramus nerve, or fasciclesthereof, that innervate a multifidus muscle, and/or nervous tissueassociated with a dorsal root ganglia nerve. The stimulation of both thedorsal ramus nerve, or fascicles thereof, that innervate a multifidusmuscle, and the nervous tissue associated with a dorsal root ganglianerve may occur simultaneously, in an interleaved manner, and/ordiscretely. In addition, the dorsal ramus nerve, or fascicles thereof,may be stimulated at the same or different stimulation parameters thanthe stimulation parameters used for the nervous tissue associated withthe dorsal root ganglia nerve.

The electrode lead may have a strain relief portion. In addition, theelectrode lead may include a first fixation element, and a secondfixation element distal to the first fixation element, wherein the firstfixation element is angled distally relative to the electrode lead andthe second fixation element is angled proximally relative to theelectrode lead in a deployed state. As such, the first and secondfixation elements may sandwich a first anchor site, e.g., muscle tissuesuch as the intertransversarii, therebetween to anchor the electrodelead to the first anchor site. The second fixation element may beradially offset relative to the first fixation element such that thefirst and the second fixation elements do not overlap when collapsedinward toward the electrode lead in a delivery state and there is aspace between the distal ends of the first and second fixation elementsin the collapsed position. In addition, the electrode lead may includethird and fourth fixation elements structured similarly to the first andsecond fixation elements that may sandwich a second anchor site, e.g.,muscle, therebetween to anchor the electrode lead to the second anchorsite. In one embodiment, the fixation elements may be foldable planararms curved radially inward.

In accordance with another aspect of the present invention, a method forrestoring muscle function to the lumbar spine to treat low back painusing the kit described above is provided. First, the distal end of theelectrode lead is implanted at a first incision site so that the one ormore electrodes are disposed in or adjacent to tissue associated withcontrol of the lumbar spine, e.g., a nervous tissue, a muscle, aligament, or a joint capsule. For example, the one or more electrodesmay be implanted in or adjacent to the dorsal ramus nerve or fasciclesthereof that innervate the multifidus muscle. Next, the cliniciantunnels the tunneler, the sheath, and the tunneler tip subcutaneouslybetween the first incision site and a second incision site such that thesheath, having the tunneler disposed therein, spans the first and secondincision sites. The tunneler tip is then decoupled from the tunneler,and the tunneler is removed from the sheath while the sheath continuesto span the first and second incision sites. Next, the clinician feedsthe proximal end of the electrode lead through an end of the sheathuntil the proximal end of the electrode lead is exposed at the other endof the sheath, and then removes the sheath from the subcutaneous tunnelbetween the first and second incision sites. The proximal end of theelectrode lead is coupled to the IPG either within the second incisionsite or outside the second incision site. The IPG is implanted at thesecond incision site.

In addition, the clinician may instruct the external programmer totransfer programming data to the IPG, and the clinician or the patientmay operate the handheld activator to command the IPG to provideelectrical stimulation to stimulate the tissue, e.g., a dorsal ramusnerve, or fascicles thereof, that innervate a multifidus muscle, and/ora nervous tissue associated with a dorsal root ganglia nerve, via theone or more electrodes responsive to the programming data.

The external programmer may be coupled to a computer, e.g., aphysician's computer, configured to run software. The softwarepreferably causes the programming data to be displayed, e.g., on thecomputer's display, and permits selection and adjustment of suchprogramming data based on user input.

The programming data transferred between the external programmer and theIPG preferably includes at least one of: pulse amplitude, pulse width,stimulation rate, stimulation frequency, ramp timing, cycle timing,session timing, or electrode configuration. For example, a physician mayadjust a stimulation rate or cause a treatment session to be started onthe external programmer or on the programming system software via thecomputer and programming data will be sent to the IPG to execute suchcommands.

The stimulation commands transferred between the activator and the IPGpreferably include at least one of: a command to start a treatmentsession or stop the treatment session; a command to provide a status ofthe implantable pulse generator; or a request to conduct an impedanceassessment. For example, a user, e.g., physician, patient, caretaker,may cause a treatment session to be started on the activator and acommand will be sent to the IPG to execute such command. The activatormay have a user interface configured to receive user input to cause astimulation command to be generated.

The one or more electrodes are configured to be implanted in or adjacentto at least one of nervous tissue, a muscle, a ligament, or a jointcapsule. The system may include a lead coupled to the IPG and having theelectrode(s) disposed thereon. The lead may be coupled to a firstfixation element configured to anchor the lead to an anchor site, e.g.,muscle, bone, nervous tissue, a ligament, and/or a joint capsule. Thelead may be further coupled to a second fixation element, distal to thefirst fixation element. In one embodiment, the first fixation element isangled distally relative to the lead and the second fixation element isangled proximally relative to the lead such that the first and secondfixation elements are configured to sandwich the anchor sitetherebetween.

The programmable controller of the IPG may be programmed with, forexample, stimulation parameters and configured to adjust stimulationparameters based on receipt of programming data from the externalprogrammer. In one embodiment, the programmable controller is programmedto direct the one or more electrodes to stimulate the tissue at a pulseamplitude between about 0.1-7 mA or about 2-5 mA, a pulse width betweenabout 20-500 μs or about 100-400 μs, and a stimulation rate betweenabout 1-20 Hz or about 15-20 Hz. In addition, the programmablecontroller may be programmed to direct the one or more electrodes tostimulate the tissue in a charge-balanced manner. Further, theprogrammable controller may be programmed to direct the one or moreelectrodes to stimulate the tissue with increasing pulse amplitudes to apeak pulse amplitude and then stimulate with decreasing pulseamplitudes. In one embodiment, the programmable controller is programmedto direct the one or more electrodes to stimulate the dorsal ramus nervethat innervates the multifidus muscle. The programmable controller alsomay be programmed to direct the one or more electrodes to stimulate thefascicles of the dorsal ramus nerve that innervates the multifidusmuscle.

The first, second, and/or third communication circuits may be inductiveand/or employ RF transceivers.

In one embodiment, the handheld activator includes a pad coupled to ahandheld housing by a cable. Preferably, the cable has a sufficientlength to enable a user to place the pad in extracorporeal proximity tothe IPG while viewing the handheld housing.

In accordance with another aspect of the present invention, a method forrestoring muscle function of the lumbar spine to reduce back pain isprovided. The method includes providing one or more electrodes, animplantable pulse generator, an external programmer, and a handheldactivator; implanting the one or more electrodes in or adjacent totissue associated with control of the lumbar spine; implanting theimplantable pulse generator in communication with the one or moreelectrodes; transferring programming data to the implantable pulsegenerator from the external programmer; and operating the handheldactivator to command the implantable pulse generator to stimulate thetissue with the one or more electrodes responsive to the programmingdata.

V. BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic view of an exemplary embodiment of a stimulatorsystem constructed in accordance with the principles of the presentinvention.

FIG. 2A shows an exemplary electrode lead of the stimulator system ofFIG. 1.

FIGS. 2B and 2C show alternative orientations of the fixation elementsof FIG. 2A, wherein FIG. 2B shows a side view of an exemplary electrodelead and FIG. 2C shows a front view of the lead of FIG. 2B.

FIG. 2D illustrates another exemplary electrode lead having first andsecond subsets of electrodes and additional fixation elements.

FIG. 2E shows an alternative of the electrode lead of FIG. 2D, whereinthe electrode lead only includes fixation elements at the first subsetof electrodes, but not at the second subset.

FIG. 2F shows another embodiment of the electrode lead of FIG. 2D, withan alternative arrangement of fixation elements at the second subset ofelectrodes.

FIG. 2G shows an alternative embodiment of an electrode lead for use inthe stimulator system, wherein the lead is transitionable between foldedand planar positions.

FIG. 3A shows an exemplary implantable pulse generator (IPG) of thestimulator system of FIG. 1.

FIGS. 3B through 3D show alternative generalized block diagrams of theIPG of FIG. 3A, wherein the IPG of FIG. 3B has an inductivecommunications circuit, the IPG of FIG. 3C has a RF transceivercommunications circuit, and the IPG of FIG. 3D has an inductivecommunications circuit and a RF transceiver communications circuit.

FIG. 4A shows an exemplary activator of the stimulator system of FIG. 1.

FIGS. 4B and 4C show alternative generalized block diagrams of theactivator of FIG. 4A, wherein the activator of FIG. 4B has an inductivecommunications circuit and the activator of FIG. 4C has a RF transceivercommunications circuit.

FIG. 5A shows an exemplary external programmer of the stimulator systemof FIG. 1.

FIGS. 5B and 5C show alternative generalized block diagrams of theexternal programmer of FIG. 5A, wherein the external programmer of FIG.5B has an inductive communications circuit and the external programmerof FIG. 5C has a RF transceiver communications circuit.

FIG. 6 is a block diagram of the functional components of an exemplarysoftware-based programming system of the stimulator system of FIG. 1.

FIGS. 7A through 7D show an exemplary method for implanting a distal endof an electrode lead in accordance with the principles of the presentinvention.

FIGS. 7E through 7G show another exemplary method for implanting adistal end of another electrode lead in accordance with the principlesof the present invention.

FIG. 7H shows the distal ends of multiple electrode leads implantedusing the exemplary method of FIGS. 7A through 7D.

FIG. 7I shows components of an exemplary tunneler system for tunnelingthe proximal end of an electrode lead subcutaneously for coupling to anIPG.

FIG. 7J shows the components of the tunneler system of FIG. 7I in anassembled state.

FIG. 7K illustrates a flow chart of an exemplary method for using thetunneler system of FIGS. 7I and 7J to tunnel the proximal end of anelectrode lead subcutaneously for coupling to an IPG.

FIG. 8 shows a graph depicting an exemplary charge-balanced electricalstimulation waveform that may be delivered by the electrodes and IPG ofthe present invention.

FIG. 9 shows a graph depicting an exemplary stimulation pulse train thatmay be delivered by the electrodes and IPG of the present invention.

FIG. 10 shows a graph depicting an exemplary session that may bedelivered by the electrodes and IPG of the present invention.

FIGS. 11-15 are exemplary screenshots illustrating various aspects ofthe user interface of the software-based programming system of thepresent invention.

VI. DETAILED DESCRIPTION OF THE INVENTION

The neuromuscular stimulation system of the present invention comprisesimplantable devices for facilitating electrical stimulation to tissuewithin a patient's back and external devices for wirelesslycommunicating programming data and stimulation commands to theimplantable devices. The devices disclosed herein may be utilized tostimulate tissue associated with local segmental control of the lumbarspine in accordance with the programming data to rehabilitate the tissueover time. In accordance with the principles of the present invention,the stimulator system may be optimized for use in treating back pain ofthe lumbar spine.

Referring to FIG. 1, an overview of an exemplary stimulator systemconstructed in accordance with the principles of the present inventionis provided. In FIG. 1, components of the system are not depicted toscale on either a relative or absolute basis. Stimulator system 100includes electrode lead 200, implantable pulse generator (IPG) 300,activator 400, optional magnet 450, external programmer 500, andsoftware-based programming system 600.

Electrode lead 200 includes lead body 202 having a plurality ofelectrodes, illustratively, electrodes 204, 206, 208, and 210. Electrodelead 200 is configured for implantation in or adjacent to tissue, e.g.,nervous tissue, muscle, a ligament, and/or a joint capsule includingtissue associated with local segmental control of the lumbar spine.Electrode lead 200 is coupled to IPG 300, for example, via connectorblock 302. IPG 300 is configured to generate pulses such that electrodes204, 206, 208, and/or 210 deliver neuromuscular electrical stimulation(“NMES”) to target tissue. In one embodiment, the electrodes arepositioned to stimulate a peripheral nerve where the nerve entersskeletal muscle, which may be one or more of the multifidus, transverseabdominus, quadratus lumborum, psoas major, internus abdominus, obliquusexternus abdominus, and erector spinae muscles. Such stimulation mayinduce contraction of the muscle to restore neural control andrehabilitate the muscle, thereby improving muscle function of localsegmental muscles of the lumbar spine, improving lumbar spine stability,and reducing back pain.

IPG 300 is controlled by, and optionally powered by, activator 400,which includes control module 402 coupled to pad 404, e.g., via cable406. Control module 402 has user interface 408 that permits a user,e.g., patient, physician, caregiver, to adjust a limited number ofoperational parameters of IPG 300 including starting and stopping atreatment session. Control module 402 communicates with IPG 300 via pad404, which may comprise an inductive coil or RF transceiver configuredto communicate information in a bidirectional manner across a patient'sskin to IPG 300 and, optionally, to transmit power to IPG 300.

Stimulator system 100 also may include optional magnet 450 configured totransmit a magnetic field across a patient's skin to IPG 300 such that amagnetic sensor of IPG 300 senses the magnetic field and IPG 300 startsor stops a treatment session responsive to the sensed magnetic field.

In FIG. 1, software-based programming system 600 is installed and runson a conventional laptop computer, and is used by the patient'sphysician together with external programmer 500 to provide programmingto IPG 300. During patient visits, external programmer 500 may becoupled, either wirelessly or using a cable such as cable 502, to thephysician's computer such that software-based programming system 600 maydownload for review data stored on IPG 300 via external programmer 500.Software-based programming system 600 also may transfer programming datato IPG 300 via external programmer 500 to reprogram stimulationparameters programmed into IPG 300. For example, programming system 600may be used to program and adjust parameters such as pulse amplitude(voltage or current), pulse width, stimulation rate, stimulationfrequency, ramp timing, cycle timing, session timing, and electrodeconfiguration. Programming system 600 also may be configured to uploadand store data retrieved from IPG 300 to a remote server for lateraccess by the physician.

Referring now to FIGS. 2A-2G, various embodiments of the electrode leadare described. In FIG. 2A, an exemplary embodiment of electrode lead 200is described. Electrode lead 200 contains a plurality of electrodes 204,206, 208, and 210, disposed at distal end 211 of lead body 202, that areconfigured to be implanted in or adjacent to tissue, such as nervoustissue, muscle, ligament, and/or joint capsule. Lead body 202 is asuitable length for positioning the electrodes in or adjacent to targettissue while IPG is implanted in a suitable location, e.g., the lowerback. For example, lead body 202 may be between about 30 and 80 cm inlength, and preferably about 45 or about 65 cm in length. Lead body 202is also of a suitable diameter for placement, for example, between about1 and 2 mm in diameter and preferably about 1.3 mm. Electrodes 204, 206,208, and 210 may be configured to stimulate the tissue at a stimulationfrequency and at a level and duration sufficient to cause muscle tocontract and may be ring electrodes, partial electrodes, segmentedelectrodes, nerve cuff electrodes placed around the nerve innervatingthe target muscle, or the like. Electrodes 204, 206, 208, 210 are asuitable length(s) and spaced apart a suitable distance along lead body202. For example, electrodes 204, 206, 208, 210 may be about 2-5 mm inlength, and preferably about 3 mm, and may be spaced apart about 2-6 mm,and preferably about 4 mm. As will also be understood by one of skill inthe art, an electrode lead may contain more or fewer than fourelectrodes.

Also at distal end 211, first and second fixation elements 212 and 214are coupled to lead body 202 via first and second fixation rings 216 and218, respectively. First and second fixation elements 212 and 214 areconfigured to sandwich an anchor site, e.g., muscle, therebetween tosecure electrode lead 200 at a target site without damaging the anchorsite. First and second fixation elements 212 and 214 may include anynumber of projections, generally between 1 and 8 each and preferably 3or 4 each. The radial spacing between the projections along therespective fixation ring is defined by the anchor site around which theyare to be placed. Preferably, the projections of first and secondfixation elements 212 and 214 are equidistally spaced apart radially,i.e., 180 degrees with two projections, 120 degrees with threeprojections, 90 degrees with four projections, etc. First fixationelements 212 are angled distally relative to lead body 202, and resistmotion in the first direction and prevent, in the case illustrated,insertion of the lead too far, as well as migration distally. Secondfixation elements 214 are angled proximally relative to lead body 202and penetrate through a tissue plane and deploy on the distal side ofthe tissue immediately adjacent to the target of stimulation. Firstfixation elements 212 are configured to resist motion in the oppositedirection relative to second fixation elements 214. This combinationprevents migration both proximally and distally, and also in rotation.In the illustrated embodiment, first fixation elements 212 arepositioned between electrode 208 and distal most electrode 210 andsecond fixation elements 214 are positioned between distal mostelectrode 210 and end cap 220. The length of and spacing between thefixation elements is defined by the structure around which they are tobe placed. In one embodiment, the length of each fixation element isbetween about 1.5-4 mm and preferably about 2.5 mm and the spacing isbetween about 2 mm and 10 mm and preferably about 6 mm. First and secondfixation elements 212 and 214 are configured to collapse inward towardlead body 202 in a delivery state and to expand, e.g., due to retractionof a sheath, in a deployed state.

Referring now to FIGS. 2B and 2C, an alternative embodiment of electrodelead 200 is described. Electrode lead 200′ is constructed similarly toelectrode lead 200 of FIG. 2A, wherein like components are identified bylike-primed reference numbers. Thus, for example, lead body 202′ inFIGS. 2B and 2C corresponds to lead body 202 of FIG. 2A, etc. As will beobserved by comparing FIGS. 2B and 2C with FIG. 2A, electrode lead 200′includes fixation elements that are radially offset with respect to eachother. For example, first fixation elements 212′ may be configured to beradially offset relative to second fixation elements 214′ byprefabricating at least one of first fixation ring 216′ and secondfixation ring 218′ relative to lead body 202′ such that at least one offirst fixation elements 212′ and second fixation elements 214′ isradially offset with respect to the other. For example, as illustratedin FIG. 2C, first fixation elements 212′ has three projections 203 andsecond fixation elements 214′ has three projections 205 and, preferably,projections 203 are radially offset relative to projections 205 by apredetermined angle, e.g., approximately 60 degrees. However, asappreciated by one of ordinary skill in the art, projections 203 may beradially offset relative to projections 205 by other angles to achievethe benefits in accordance with the present invention described below.Projections 203 and 205 may be formed of a flexible material, e.g., apolymer, and may be collapsible and self-expandable when deployed. Forexample, projections 203 and 205 may collapse inward toward lead body202′ in a delivery state such that projections 203 and 205 are generallyparallel to the longitudinal axis of lead body 202′ within a sheath. Inthe delivery state, the radially offset first and second fixationelements 212′ and 214′ need not overlap within a sheath. Further,projections 203 and 205 may expand, e.g., due to retraction of thesheath, in a deployed state such that projections 203 are angleddistally relative to lead body 202′, and resist motion in the firstdirection and prevent, in the case illustrated, insertion of the leadtoo far, as well as migration distally, and projections 205 are angledproximally relative to lead body 202′ to resist motion in an oppositedirection relative to first fixation elements 212′. This combinationprevents migration of the lead both proximally and distally, and also inrotation.

Referring now to FIG. 2D, another embodiment of electrode lead 200 isdescribed. Electrode lead 200″ is constructed similarly to electrodelead 200 of FIG. 2A, wherein like components are identified bylike-primed reference numbers. Thus, for example, lead body 202″ in FIG.2D corresponds to lead body 202 of FIG. 2A, etc. As will be observed bycomparing FIG. 2D with FIG. 2A, electrode lead 200″ includes additionalelectrodes and fixation elements distal to the first and second fixationelements. Specifically, electrode lead 200″ contains a first subset ofelectrodes comprising electrodes 204″, 206″, 208″, and 210″, disposedalong lead body 202″, that are configured to be implanted in or adjacentto tissue, such as nervous tissue, muscle, ligament, and/or jointcapsule. Further, electrode lead 200″ contains a second subset ofelectrodes comprising electrodes 254 and 256, disposed at the distal endof lead body 202″ distal to the first subset of electrodes, that areconfigured to be implanted in or adjacent to the same or differenttissue, such as nervous tissue, muscle, ligament, and/or joint capsule.For example, in one embodiment, one or more electrodes of the firstsubset of electrodes are configured to be implanted in or adjacent tothe dorsal ramus nerve or fascicles thereof for stimulation and one ormore electrodes of the second subset of electrodes are configured to beimplanted in or adjacent to the dorsal root ganglion for stimulation.Lead body 202″ may be structurally similar to lead body 200 of FIG. 2Adescribed above and is a suitable length for positioning the first andsecond subset of electrodes in or adjacent to target tissue(s) while theIPG is implanted in a suitable location, e.g., the lower back, althoughlead body 202″ may be extended at the distal end of additionalelectrodes, Electrodes 204″, 206″, 208″, 210″, 254 and 256 may beconfigured to stimulate the tissue(s) at a stimulation frequency and ata level and duration sufficient to cause muscle to contract and may bering electrodes, partial electrodes, segmented electrodes, nerve cuffelectrodes placed around the nerve innervating the target muscle, or thelike. Alternatively, the first subset of electrodes may be configured tostimulate the respective target tissue with a stimulation regime, e.g.,stimulation frequency, level, and duration, that is different from thestimulation regime utilized by the second subset of electrodes tostimulate the respective target tissue. Electrodes 204″, 206″, 208″,210″, 254 and 256 may be structurally similar, with regard to length andspacing, to the electrodes of FIG. 2A described above. Further, thefirst subset of electrodes may be spaced apart a suitable distance fromthe second subset of electrodes, such that the electrode lead maystimulate different portions of the same tissue or different tissuessimultaneously and/or substantially simultaneously. As will also beunderstood by one of skill in the art, the first subset of electrodesmay contain more or fewer than four electrodes and the second subset ofelectrodes may contain more or fewer than two electrodes on lead body202″.

Also at a location along lead body 202″, first and second fixationelements 212″ and 214″ are coupled to lead body 202″ via first andsecond fixation rings 216″ and 218″, respectively, and in proximity toat least one electrode of the first subset of electrodes. Additionallyat the distal end of lead body 202″, third and fourth fixation elements262 and 264 are coupled to lead body 202″ via third and fourth fixationrings 266 and 268, respectively, and in proximity to at least oneelectrode of the second subset of electrodes. First and second fixationelements 212″ and 214″ are configured to sandwich a first anchor site,e.g., muscle such as the intertransversarii or nervous tissue,therebetween to secure the first subset of electrodes of electrode lead200″ at a target site without damaging the first anchor site. Third andfourth fixation elements 262 and 264 are configured to sandwich a secondanchor site, e.g., muscle or nervous tissue, therebetween to secure thesecond subset of electrodes of electrode lead 200″ at another targetsite without damaging the second anchor site.

First and second fixation elements 212″ and 214″ and third and fourthfixation elements 262 and 264 may be structurally similar, with regardto length and spacing, to the fixation elements of FIG. 2A describedabove. Fixation elements 212″, 214″, 262, and 264 are configured tocollapse inward toward lead body 202″ in a delivery state and to expand,e.g., due to retraction of a sheath, in a deployed state. Similar to theembodiment illustrated in FIGS. 2B and 2C, second fixation element 214″may be configured to be radially offset relative to first fixationelement 212″ by prefabricating and coupling first fixation ring 216″ tolead body 202″ offset a predetermined angle from second fixation ring218″ such that the projections are offset from one another by thepredetermined angle, e.g., 60 degrees. Similarly, third fixation element262 may be configured to be radially offset relative to fourth fixationelement 264 by prefabricating and coupling third fixation ring 266 tolead body 202″ offset a predetermined angle from fourth fixation ring268 such that the projections are offset from one another by thepredetermined angle, e.g., 60 degrees. Thus, first fixation element 212″and second fixation element 214″ need not overlap in the delivery statewithin the sheath, and third fixation element 262 and fourth fixationelement 264 need not overlap in the delivery state within the sheath.

In addition, first and fourth fixation elements 212″ and 264 are angleddistally relative to lead body 202″ in a deployed state, and resistmotion in a first direction and prevent, in the case illustrated,insertion of the lead too far, as well as migration distally. Second andthird fixation elements 214″ and 262 are angled proximally relative tolead body 202″ in a deployed state, and resist motion in a seconddirection opposite to the first direction. This combination preventsmigration both proximally and distally, and also in rotation. In theillustrated embodiment, first fixation elements 212″ are positionedbetween electrode 208″ and electrode 210″ and second fixation elements214″ are positioned between electrode 210″ and electrode 254. Thirdfixation elements 262 are positioned between distal most electrode 256and distal cap 220″ and fourth fixation elements 264 are positionedbetween electrode 254 and distal most electrode 256.

Referring now to FIG. 2E, another embodiment of electrode lead 200 isdescribed. Electrode lead 200′″ is constructed similarly to electrodelead 200 of FIG. 2A, wherein like components are identified bylike-primed reference numbers. Thus, for example, lead body 202′″ inFIG. 2E corresponds to lead body 202 of FIG. 2A, etc. As will beobserved by comparing FIG. 2E with FIG. 2A, electrode lead 200′″includes additional electrodes distal to the first and second fixationelements. Specifically, electrode lead 200′″ may include a first subsetof electrodes comprising electrodes 206′″, 208′″ and 210′″ and a secondsubset of electrodes comprising electrodes 254′ and 256′. The secondsubset of electrodes are positioned distal to the first subset ofelectrodes relative to lead body 202′″. Electrode lead 200′″ may furtherinclude first and second fixation elements 212′″ and 214′″ along leadbody 202′″ in proximity to at least one electrode of the first subset ofelectrodes. In the illustrated embodiment, first fixation elements 212′″are positioned between electrode 208′″ and electrode 210′″ and secondfixation elements 214′″ are positioned between electrode 210′″ andelectrode 254′. As will also be understood by one of skill in the art,the first subset of electrodes may contain more or fewer than threeelectrodes and the second subset of electrodes may contain more or fewerthan two electrodes on lead body 202′″, and the first and second subsetsof electrodes may be structurally similar to the first and secondsubsets of electrodes described in FIG. 2D above.

Similar to the embodiment illustrated in FIGS. 2B and 2C, secondfixation elements 214′″ may be configured to be radially offset relativeto first fixation elements 212′″ by prefabricating and coupling firstfixation ring 216′″ to lead body 202″ offset a predetermined angle fromsecond fixation ring 218″ such that the projections are offset from oneanother by the predetermined angle, e.g., 60 degrees. In addition, firstfixation elements 212′″ is angled distally relative to lead body 202′″in a deployed state, and resist motion in a first direction and prevent,in the case illustrated, insertion of the lead too far, as well asmigration distally. Second fixation elements 214′″ is angled proximallyrelative to lead body 202′″ in a deployed stated, and resist motion in asecond direction opposite to the first direction. This combinationprevents migration both proximally and distally, and also in rotation.

Referring now to FIG. 2F, another embodiment of electrode lead 200 isdescribed. Electrode lead 200″″ is constructed similarly to electrodelead 200 of FIG. 2A, wherein like components are identified bylike-primed reference numbers. Thus, for example, lead body 202″″ inFIG. 2F corresponds to lead body 202 of FIG. 2A, etc. As will beobserved by comparing FIG. 2F with FIG. 2A, electrode lead 200″″includes three fixation elements rather than four fixation elements.Specifically, FIG. 2F illustrates an embodiment where the electrode leadmay include first, second, and third fixation elements 212″″, 214″″, and262′. In the illustrated embodiment, first fixation elements 212″″ arepositioned between electrode 208″″ and electrode 210″″, second fixationelements 214″″ are positioned between electrode 210″″ and electrode254″, and third fixation elements 262′ are positioned between distalmost electrode 256″ and end cap 220′″. As will also be understood by oneof skill in the art, the fixation elements may be positioned along theelectrode lead to secure any one of the other electrodes disposedthereon at a target site.

While FIG. 2A illustrates fixation elements 212 and 214 on lead body202, it should be understood that other fixation elements may be used toanchor electrode lead 200 at a suitable location including the fixationelements described in U.S. Pat. No. 9,079,019 to Crosby and U.S. PatentApplication Pub. No. 2013/0338730 to Shiroff, both assigned to theassignee of the present invention, the entire contents of each of whichis incorporated herein by reference. For example, FIG. 2G illustratesplanar foldable lead body 201 and fixation elements 246, 248 and 250.Fixation elements 246, 248 and 250 are foldable planar arms,transitionable between a folded position in a delivery state and aplanar position or a partially planar position in a deployed state.Further, fixation elements 246, 248 and 250 may be curved radiallyinward to facilitate in recruiting muscle or nervous tissue and/or toanchor the electrode lead at a suitable location. Lead body 201 andfixation elements 246, 248 and 250 may collapse radially inward in adelivery state and may expand, e.g., due to retraction of a sheath, in adeployed state. In addition, lead body 201 may include flexibleelectrodes 232, 234, 236, 238, 240, 242, and 244 along lead body 201.The electrodes may be partial cuff electrodes, or any flexible electrodecommercially available capable of curving radially inward along withlead body 201 in a delivery state, and expanding in a deployed state. Aswill be understood by one of skill in the art, lead body 201 may containmore or fewer than seven electrodes.

Lead body 202 further includes stylet lumen 222 extending therethrough.Stylet lumen 222 is shaped and sized to permit a stylet to be insertedtherein, for example, during delivery of electrode lead 200. In oneembodiment, end cap 220 is used to prevent the stylet from extendingdistally out of stylet lumen 222 beyond end cap 220.

Lead body 202 may include an elastic portion as described in U.S. PatentApplication Pub. No. 2013/0338730 to Shiroff, or U.S. Patent ApplicationPub. No. 2014/0350653 to Shiroff, both assigned to the assignee of thepresent invention, the entire contents of both of which are incorporatedherein by reference.

At proximal end 224, electrode lead 200 includes contacts 226, 228, 230,and 232 separated along lead body 202 by spacers 234, 236, 238, 240, and242. Contacts 226, 228, 230, and 232 may comprise an isodiametricterminal and are electrically coupled to electrodes 204, 206, 208, and210, respectively, via, for example, individually coated spiral woundwires. A portion of proximal end 224 is configured to be inserted in IPG300 and set-screw retainer 244 is configured to receive a screw from IPG300 to secure the portion of electrode lead 200 within IPG 300.

As would be apparent to one of ordinary skill in the art, variouselectrode locations and configurations would be acceptable, includingthe possibility of skin surface electrodes. The electrode(s) may be anarray of a plurality of electrodes, or may be a simple single electrodewhere the electrical circuit is completed with an electrode placedelsewhere (not shown) such as a skin surface patch or by the can of animplanted pulse generator. In addition, electrode lead 200 may comprisea wirelessly activated or leadless electrode, such as described in U.S.Pat. No. 8,321,021 to Kisker, such that no lead need be coupled to IPG300.

Referring to FIG. 3A, IPG 300 is configured to generate pulses forelectrical transmission to electrode lead 200. As is common with otheractive implantable medical devices, the IPG electronics are housed in ahermetically sealed metal housing 304. Housing 304 may comprise titaniumor other biocompatible material, and includes connector block 302 thatpermits electrode lead 200 to be electrically coupled to the electronicswithin housing 304 via channel 306. Channel 306 is coupled to conductors308, 310, 312, and 314 which are coupled to the IPG electronics. Whenproximal end 224 of electrode lead 200 is inserted within channel 306,conductors 308, 310, 312, and 314 are electrically coupled to contacts226, 228, 230, and 232, respectively, and, in turn, electrically coupledto electrodes 204, 206, 208, and 210, respectively. Set-screw 316 isconfigured to be tightened down on set-screw retainer 244 to secure aportion of electrode lead 200 within channel 306. IPG 300 furtherincludes a second channel (not shown) with four additional conductors.The two separate channels facilitate bilateral stimulation and theelectrode configuration, e.g., combination of positive and negativeelectrodes, may be programmed independently for each channel.

As will be appreciated by one of ordinary skill in the art, while IPG300 is illustratively implantable, a stimulator may be disposed externalto a body of a patient on a temporary or permanent basis withoutdeparting from the scope of the present invention. For example, anexternal stimulator may be coupled to the electrodes wirelessly.

With respect to FIG. 3B, a generalized schematic diagram of the internalfunctional components of IPG 300 is now described. IPG 300 may includeprogrammable controller 318, telemetry system 320 coupled to coil 322,power supply 324, electrode switching array 326, system sensors 328, andoptional therapeutic circuitry module 330.

Controller 318 is electrically coupled to, and configured to control,the internal functional components of IPG 300. Controller 318 maycomprise a commercially available microcontroller unit including aprogrammable microprocessor, volatile memory, nonvolatile memory such asEEPROM for storing programming, and nonvolatile storage, e.g., Flashmemory, for storing firmware and a log of system operational parametersand patient data. The memory of controller 318 stores programinstructions that, when executed by the processor of controller 318,cause the processor and the functional components of IPG 300 to providethe functionality ascribed to them herein. Controller 318 is configuredto be programmable such that programming data is stored in the memory ofcontroller 318 and may be adjusted using external programmer 500 asdescribed below. Programming data may include pulse amplitude (voltageor current), pulse width, stimulation rate, stimulation frequency, ramptiming, cycle timing, session timing, and electrode configuration. Inaccordance with one embodiment, programmable parameters, their ranges,and nominal values are:

Parameter Min Max Nominal Amplitude  0 mA  7.0 mA  1 mA Pulse Width  25μs 500 μs 200 μs Rate  1 Hz  40 Hz  20 Hz On Ramp  0 s  5 s  2 s OffRamp Cycle-On  2 s  20 s  10 s Cycle-Off  20 s 120 s  20 s Session  1min  60 min  30 min

Controller 318 may be programmable to allow electrical stimulationbetween any chosen combination of electrodes on the lead, thus providinga simple bipolar configuration. In addition, controller 318 may beprogrammed to deliver stimulation pulses in a guarded bipolarconfiguration (more than 1 anode surrounding a central cathode) or IPGhousing 304 may be programmed as the anode, enabling unipolarstimulation from any of the electrodes.

Controller 318 further may be programmed with a routine to calculate theimpedance at electrode lead 200. For example, controller 318 may directpower supply 324 to send an electrical signal to one or more electrodeswhich emit electrical power. One or more other electrodes receive theemitted electrical power and send a received signal to controller 318that runs the routine to calculate impedance based on the sent signaland the received signal.

Controller 318 is coupled to communications circuitry includingtelemetry system 320, which is electrically coupled to coil 322, thatpermits transmission of stimulation commands, and optionally power,between IPG 300 and activator 400 such that IPG 300 may be powered,programmed, and/or controlled by activator 400. For example, controller318 may start or stop a treatment session responsive to stimulationcommands received from a corresponding telemetry system and coil ofactivator 400 via coil 322 and telemetry system 320. Telemetry system320 and coil 322 further permit transmission of programming data, andoptionally power, between IPG 300 and external programmer 500 such thatIPG 300 may be powered, programmed, and/or controlled by software-basedprogramming system 600 via external programmer 500. For example,controller 318 may direct changes to at least one of pulse amplitude(voltage or current), pulse width, stimulation rate, stimulationfrequency, ramp timing, cycle timing, session timing, and electrodeconfiguration responsive to programming data received from acorresponding telemetry system and coil of external programmer 500 viacoil 322 and telemetry system 320.

The technology for telemetry system 320 and coil 322 is well known toone skilled in the art and may include a magnet, a short range telemetrysystem, a longer range telemetry system (such as using MICS RF Telemetryavailable from Zarlink Semiconductor of Ottawa, Canada), or technologysimilar to a pacemaker programmer. Alternatively, coil 322 may be usedto transmit power only, and separate radio frequency transmitters may beprovided in IPG 300 activator 400, and/or external programmer 500 forestablishing bidirectional or unidirectional data communication.

Power supply 324 powers the electrical components of IPG 300, and maycomprise a primary cell or battery, a secondary (rechargeable) cell orbattery or a combination of both. Alternatively, power supply 324 maynot include a cell or battery, but instead comprise a capacitor thatstores energy transmitted through the skin via a Transcutaneous EnergyTransmission System (TETs), e.g., by inductive coupling. In a preferredembodiment, power supply 324 comprises a lithium ion battery.

Controller 318 further may be coupled to electrode switching array 326so that any subset of electrodes of the electrode leads may beselectably coupled to therapeutic circuitry module 330, described indetail below. In this way, an appropriate electrode set may be chosenfrom the entire selection of electrodes implanted in the patient's bodyto achieve a desired therapeutic effect. Electrode switching array 326preferably operates at high speed, thereby allowing successivestimulation pulses to be applied to different electrode combinations.

System sensors 328 may comprise one or more sensors that monitoroperation of the systems of IPG 300, and log data relating to systemoperation as well as system faults, which may be stored in a log forlater readout using software-based programming system 600. In oneembodiment, system sensors 328 include a magnetic sensor configured tosense a magnetic field and to transmit a signal to controller 318 basedon the sensed magnetic field such that the controller starts or stops atreatment session. In another embodiment, system sensors 328 include oneor more sensors configured to sense muscle contraction and to generate asensor signal based on the muscle contraction. Controller 318 isconfigured to receive the sensor signal from system sensors 328 and toadjust the stimulation parameters based on the sensor signal. In oneembodiment, system sensors 328 sense an increase or decrease in musclemovement and controller 318 increases or decreases the stimulationfrequency to maintain smooth and continuous muscle contraction.

In one embodiment, sensors 328 may include an accelerometer that sensesacceleration of a muscle caused by muscle contraction. The accelerometermay be a 1-, 2- or 3-axis analog or digital accelerometer thatdetermines whether the patient is active or asleep or senses overallactivity of the patient, which may be a surrogate measure for clinicalparameters (e.g., more activity implies less pain), and/or a heart rateor breathing rate (minute ventilation) monitor, e.g., which may beobtained using one or more of the electrodes disposed on the electrodeleads. The accelerometer may be used to determine the orientation of IPG300, and by inference the orientation of the patient, at any time. Forexample, after implantation, software-based programming system 600 maybe used to take a reading from the implant, e.g., when the patient islying prone, to calibrate the orientation of the accelerometer. If thepatient is instructed to lie prone during therapy delivery, then theaccelerometer may be programmed to record the orientation of the patientduring stimulation, thus providing information on patient compliance. Inother embodiments, system sensors 328 may include a pressure sensor, amovement sensor, and/or a strain gauge configured to sense musclecontraction and to generate a sensor signal based on the musclecontraction, and in a further embodiment, various combinations of atleast one of an accelerometer, a pressure sensor, a movement sensor,and/or a strain gauge are included.

Sensors 328 may also include, for example, a humidity sensor to measuremoisture within housing 304, which may provide information relating tothe state of the electronic components, or a temperature sensor, e.g.,for measuring battery temperature during charging to ensure safeoperation of the battery. Data from the system sensors may be logged bycontroller 318 and stored in nonvolatile memory for later transmissionto software-based programming system 600 via external programmer 500.

As will be appreciated by one of ordinary skill in the art, systemsensors 328 may be placed in a variety of locations including withinhousing 302, within or adjacent to the tissue that is stimulated, and/orin proximity to the muscle to be contracted and connected via a separatelead to IPG 300. In other embodiments, sensors 324 may be integratedinto one or more of the leads used for stimulation or may be anindependent sensor(s) operatively coupled to IPG 300 using, for example,radio frequency (RF) signals for transmitting and receiving data.

Controller 318 also may be coupled to optional therapeutic circuitrymodule 330 that provides any of a number of complimentary therapeuticstimulation, analgesic, feedback or ablation treatment modalities asdescribed in detail below. IPG 300 illustratively includes onetherapeutic circuitry module 330, although additional circuitry modulesmay be employed in a particular embodiment depending upon its intendedapplication, as described in U.S. Pat. No. 9,248,278 to Crosby, assignedto the assignee of the present invention, the entire contents of whichis incorporated herein by reference. Therapeutic circuitry module 330may be configured to provide different types of stimulation, either toinduce muscle contractions or to block pain signals in afferent nervefibers; to monitor muscle contractions induced by stimulation and adjustthe applied stimulation regime as needed to obtain a desired result; orto selectively and intermittently ablate nerve fibers to control painand thereby facilitate muscle rehabilitation.

Referring to FIG. 3C, IPG 300′ is constructed similarly to PG 300 ofFIG. 3B, wherein like components are identified by like-primed referencenumbers. Thus, for example, power supply 324′ in FIG. 3C corresponds topower supply 324 of FIG. 3B, etc. As will be observed by comparing FIGS.3B and 3C, IPG 300′ includes a communications circuit employingtransceiver 332 coupled to antenna 334 (which may be inside or externalto the hermetic housing) rather than telemetry system 320 and coil 322of IPG 300.

Transceiver 332 preferably comprises a radio frequency (RF) transceiverand is configured for bi-directional communications via antenna 334 witha similar transceiver circuit disposed in activator 400 and/or externalprogrammer 500. For example, transceiver 332 may receive stimulationcommands from activator 400 and programming data from software-basedprogramming system 600 via external programmer 500. Controller 318 maydirect changes to at least one of pulse amplitude (voltage or current),pulse width, stimulation rate, stimulation frequency, ramp timing, cycletiming, session timing, and electrode configuration, including commandsto start or stop a treatment session, responsive to programming dataand/or stimulation commands received from a corresponding transceiverand antenna of activator 400 and/or external programmer 500 via antenna334 and transceiver 332. Transceiver 332 also may include a low powermode of operation, such that it periodically awakens to listen forincoming messages and responds only to those messages including theunique device identifier assigned to that IPG. In addition, transceiver332 may employ an encryption routine to ensure that messages sent from,or received by, IPG 300 cannot be intercepted or forged.

Referring to FIG. 3D, IPG 300″ is constructed similarly to IPG 300 ofFIG. 3B and IPG 300′ of FIG. 3C except that IPG 300″ includes acommunications circuit employing telemetry system 320″ and coil 322″ anda communications circuit employing transceiver 332″ and antenna 334″.IPG 300″ is preferably in an embodiment where IPG 300″ communicatesinductively and using RF. In one embodiment, telemetry system 320″ andcoil 322″ are configured to transfer stimulation commands, andoptionally power, between IPG 300″ and activator 400 from acorresponding telemetry system and coil of activator 400. In such anembodiment, transceiver 332″ and antenna 334″ are configured to transferprogramming data between IPG 300″ and external programmer 500′ from acorresponding transceiver and antenna of external programmer 500′. In analternative embodiment, telemetry system 320″ and coil 322″ permittransfer of programming data, and optionally power, between IPG 300″ andexternal programmer 500 from a corresponding telemetry system and coilof external programmer 500. In such an embodiment, transceiver 332″ andantenna 334″ are configured for transfer of stimulation commands betweenIPG 300″ and activator 400′ from a corresponding transceiver and antennaof activator 400′.

Referring now to FIG. 4A, exemplary activator 400, including controlmodule 402 and pad 404, is described. Control module 402 includeshousing 410 sized for handheld use and user interface 408. Userinterface 408 permits a user, e.g., patient, physician, caregiver, toadjust a limited number of operational parameters of IPG 300 includingstarting and stopping a treatment session. Illustratively, userinterface 408 includes signal LED 412, status LED 414, warning LED 416,start button 418, stop button 420, status button 422, and battery LED424. Signal LED 412 preferably contains multiple diodes, each of whichemit light of a different preselected color. Signal LED 412 isconfigured to illuminate when the communications circuit within pad 404detects a suitable connection with a the corresponding communicationscircuit in IPG 300 suitable for power transmission and/or datacommunication between IPG 300 and activator 400. In one embodiment,signal LED 412 illuminates a red diode when there is not a suitableconnection, a yellow diode when the connection is suitable but weak, anda green diode when the connection is suitable and strong. Status LED 414also may include multiple diodes that illuminate in a pattern of flashesand/or colors to indicate to the user the status of IPG 300. Suchpatterns are stored in the memory of the controller of control module402 and may indicate whether the IPG is directing stimulation to occuror awaiting commands. A user may refer to a user manual to decode apattern shown on status LED 414. Warning LED 416 is configured toilluminate when the controller of control module 402 detects an errorand indicates that a user should contact their physician or clinic. Whenstart button 418 is pressed, the controller of control module 402directs a signal to be sent to IPG 300 via pad 404 and cable 406 tobegin a treatment session. When stop button 420 is pressed, thecontroller of control module 402 directs a signal to be sent to IPG 300via pad 404 and cable 406 to end a treatment session. Alternatively, thetreatment session may have a predetermined length and the controllerde-energizes the electrodes when the session time expires. Battery LED424 is configured to illuminate when the controller in control module402 detects that the battery levels are below a predetermined threshold.

Pad 404 is configured to communicate information and, optionally,transfer power from control module 402 to IPG 300 in a bidirectionalmanner across a patient's skin. In one embodiment, pad 404 includes aninductive coil within its housing. Cable 406 is a suitable length sothat a patient may comfortably place pad 404 in extracorporeal proximityto IPG 300 implanted in the patient's lower back while viewing controlmodule 402 to confirm correct placement using signal LED 412.

With respect to FIG. 4B, a generalized schematic diagram of the internalfunctional components of activator 400 is now described. Activator 400may include programmable controller 426, telemetry system 428 coupled tocoil 430, user interface 432, power supply 434, and input and outputcircuitry (I/O) 436. In a preferred embodiment, programmable controller426, telemetry system 428, user interface 432, power supply 434, andinput and output circuitry (I/O) 436 are housed within control modulehousing 410 and coil 430 is housed within the housing for pad 404.

Controller 426 is electrically coupled to, and configured to control,the internal functional components of activator 400. Controller 426 maycomprise a commercially available microcontroller unit including aprogrammable microprocessor, volatile memory, nonvolatile memory such asEEPROM for storing programming, and nonvolatile storage, e.g., Flashmemory, for storing firmware and a log of system operational parametersand patient data. The memory of controller 426 may store programinstructions that, when executed by the processor of controller 426,cause the processor and the functional components of activator 400 toprovide the functionality ascribed to them herein. Controller 426 isconfigured to be programmable. For example, controller 426 may sendstimulation commands responsive to user input received at user interface432 to controller 318 of IPG 300 via the telemetry (or RF) systems tostart or stop a treatment session. In a preferred embodiment, a limitednumber of stimulation parameters may be adjusted at user interface 432to minimize the chance of injury caused by adjustments made bynon-physician users. In an alternative embodiment, controller 426 alsomay send adjustments to stimulation parameters, e.g., pulse amplitude(voltage or current), pulse width, stimulation rate, stimulationfrequency, ramp timing, cycle timing, session timing, and electrodeconfiguration to IPG 300 responsive to user input received at userinterface 432.

Controller 426 is coupled to telemetry system 428, which is electricallycoupled to coil 430 (e.g., via cable 406), that permits transmission ofenergy and stimulation commands between activator 400 and IPG 300 (orIPG 300″) such that IPG 300 may be powered, programmed, and/orcontrolled by activator 400 responsive to user input received at userinterface 432. For example, controller 426 may direct telemetry system428 and coil 430 to send adjustments to stimulation parameter(s),including commands to start or stop a treatment session or providestatus of the IPG, responsive to user input received at user interface432 to coil 322 and telemetry system 320 of IPG 300. The technology fortelemetry system 428 and coil 430 is well known to one skilled in theart and may be similar to telemetry system 320 and coil 322 describedabove. Alternatively, coil 430 may be used to transmit power only, andseparate radio frequency transmitters may be provided in activator 400and IPG 300 for establishing bidirectional or unidirectional datacommunication.

User interface 432 is configured to receive user input and to displayinformation to the user. As described above, user interface 432 mayinclude buttons for receiving user input and LEDs for displayinginformation to the user. As will be readily apparent to one skilled inthe art, user interface 432 is not limited thereto and may use adisplay, a touch screen, a keypad, a microphone, a speaker, a trackball,or the like.

Power supply 434 powers the electrical components of activator 400, andmay comprise a primary cell or battery, a secondary (rechargeable) cellor battery or a combination of both. Alternatively, power supply 434 maybe a port to allow activator 400 to be plugged into a conventional wallsocket for powering components.

Input and output circuitry (I/O) 436 may include ports for datacommunication such as wired communication with a computer and/or portsfor receiving removable memory, e.g., SD card, upon which programinstructions or data related to activator 400 use may be stored.

Referring to FIG. 4C, activator 400′ is constructed similarly toactivator 400 of FIG. 4B except that activator 400′ includes acommunications circuit employing transceiver 438 and antenna 440 ratherthan a communications circuit employing telemetry system 428 and coil430. Transceiver 438 preferably comprises a radio frequency (RF)transceiver and is configured for bi-directional communications viaantenna 440 with transceiver 332 via antenna 334 of IPG 300′.Transceiver 438 may transmit stimulation commands from activator 400′ toIPG 300′ (or IPG 300″). For example, controller 426′ may directtransceiver 438 to transmit commands to start or stop a treatmentsession to IPG 300′ responsive to user input received at user interface432′. In one embodiment, controller 426′ may direct transceiver 438 totransmit a command to provide status of IPG 300′ or commands to adjuststimulation parameter(s) to IPG 300′ responsive to user input receivedat user interface 432′.

Transceiver 438 also may include a low power mode of operation, suchthat it periodically awakens to listen for incoming messages andresponds only to those messages including the unique device identifierassigned to that activator. In addition, transceiver 438 may employ anencryption routine to ensure that messages sent from, or received by,activator 400′ cannot be intercepted or forged.

Referring now to FIG. 5A, exemplary external programmer 500 is nowdescribed. External programmer 500 includes housing 504 sized forhandheld use and user interface 506. User interface 506 permits a user,e.g., patient, physician, caregiver, to send programming data to IPG 300including commands to adjust stimulation parameters. Illustratively,user interface 506 includes status LED 508, status button 510, andsignal LEDs 512. Status LED 508 is configured to illuminate when statusbutton 510 is pressed to indicate a successful communication has beensent to IPG 300, e.g., command to stop a treatment session. Signal LEDs512 are configured to illuminate based on the strength of the signalbetween IPG 300 and external programmer 500. The controller of externalprogrammer 500 may direct appropriate signal LEDs 512 to illuminatebased on the strength of the signals between the respective telemetrysystems and coils or transceivers and antennas of external programmer500 and IPG 300. Signal LEDs 512 may include diodes with differentcolors. For example, signal LEDs 512 may include red diodes configuredto illuminate when the signal strength between external programmer 500and IPG 300 is weak or non-existent, yellow diodes configured toilluminate when the signal strength between external programmer 500 andIPG 300 is medium, and green diodes configured to illuminate when thesignal strength between external programmer 500 and IPG 300 is strong.External programmer 500 further includes port 514 configured to receivecable 502 such that external programmer 500 is electrically coupled andmay communicate programming data with software-based programming system600 run on a computer.

With respect to FIG. 5B, a generalized schematic diagram of the internalfunctional components of external programmer 500 is now described.External programmer 500 may include programmable controller 516,telemetry system 518 coupled to coil 520, user interface 522, powersupply 524, and input and output circuitry (I/O) 526.

Controller 516 is electrically coupled to, and configured to control,the internal functional components of external programmer 500.Controller 516 may comprise a commercially available microcontrollerunit including a programmable microprocessor, volatile memory,nonvolatile memory such as EEPROM for storing programming, andnonvolatile storage, e.g., Flash memory, for storing firmware and a logof system operational parameters and patient data. The memory ofcontroller 516 may store program instructions that, when executed by theprocessor of controller 516, cause the processor and the functionalcomponents of external programmer 500 to provide the functionalityascribed to them herein. Controller 516 is configured to be programmablesuch that stimulation parameters, e.g., pulse amplitude (voltage orcurrent), pulse width, stimulation rate, stimulation frequency, ramptiming, cycle timing, session timing, and electrode configuration may beadjusted responsive to user input received at user interface 522. Forexample, controller 516 may send programming data responsive to userinput received at user interface 522 to controller 318 of IPG 300 viathe respective telemetry (or RF) systems to adjust stimulationparameters or to start or stop a treatment session. In a preferredembodiment, only a physician has access to external programmer 500 tominimize the chance of injury caused by adjustments made bynon-physician users.

Controller 516 is coupled to telemetry system 518, which is electricallycoupled to coil 520, that permits transmission of programming data, andoptionally power, between software-based programming system 600 and IPG300 (or IPG 300″) via external programmer 500. In this manner, IPG 300may be powered, programmed, and/or controlled by software-basedprogramming system 600 and external programmer 500 responsive to userinput received at user interface 522. For example, controller 516 maydirect telemetry system 518 to transmit stimulation parameter(s) such aspulse amplitude (voltage or current), pulse width, stimulation rate,stimulation frequency, ramp timing, cycle timing, session timing, andelectrode configuration, including commands to start or stop a treatmentsession, to IPG 300 responsive to user input received at user interface522 and/or software-based programming system 600. As another example,controller 516 may direct telemetry system 518 to transmit interrogationcommands such as requests for the actual value of stimulationparameter(s), battery voltage, data logged at IPG 300, and IPG 300status data, to IPG 300 responsive to user input received at userinterface 522 and/or software-based programming system 600, and toreceive responses to the interrogation commands from IPG 300. As yetanother example, controller 516 may direct telemetry system 518 totransmit commands to IPG 300 to calculate the impedance of electrodelead 200 using a routine stored on controller 318 of IPG 300 and toreceive the calculated lead impedance from the telemetry system of IPG300. The technology for telemetry system 518 and coil 520 is well knownto one skilled in the art and may be similar to telemetry system 320 andcoil 322 described above. Alternatively, coil 520 may be used totransmit power only, and separate radio frequency transmitters may beprovided in external programmer 500 and IPG 300 for establishingdirectional data communication.

User interface 522 is configured to receive user input and to displayinformation to the user. As described above, user interface 522 mayinclude buttons for receiving user input and LEDs for displayinginformation to the user. As will be readily apparent to one skilled inthe art, user interface 522 is not limited thereto and may use adisplay, a touch screen, a keypad, a microphone, a speaker, a trackball,or the like.

Power supply 524 powers the electrical components of external programmer500, and may comprise a primary cell or battery, a secondary(rechargeable) cell or battery or a combination of both. Alternatively,power supply 524 may be a port to allow external programmer 524 to beplugged into a conventional wall socket for powering components. In onepreferred embodiment, power supply 524 comprises a USB port and cablethat enables external programmer 500 to be powered from a computer,e.g., via cable 502, running software-based programming system 600.

Input and output circuitry (I/O) 526 may include ports for datacommunication such as wired communication with a computer and/or portsfor receiving removable memory, e.g., SD card, upon which programinstructions or data related to external programmer 500 use may bestored. In one embodiment, I/O 526 comprises port 514, and correspondingcircuitry, for accepting cable 502 such that external programmer 500 iselectrically coupled to a computer running software-based programmingsystem 600.

Referring to FIG. 5C, external programmer 500′ is constructed similarlyto external programmer 500 of FIG. 5B except that external programmer500′ includes a communications circuit employing transceiver 528 andantenna 530 rather than a communications circuit employing telemetrysystem 518 and coil 520. Transceiver 528 preferably comprises a radiofrequency (RF) transceiver and is configured for bi-directionalcommunications via antenna 530 with transceiver 332 via antenna 334 ofIPG 300′. Transceiver 528 may transmit programming data from externalprogrammer 500′ to IPG 300′ (or IPG 300″). For example, controller 516′may direct transceiver 528 to transmit stimulation parameter(s) such aspulse amplitude (voltage or current), pulse width, stimulation rate,stimulation frequency, ramp timing, cycle timing, session timing, andelectrode configuration, including commands to start or stop a treatmentsession, to IPG 300′ responsive to user input received at user interface522′ and/or software-based programming system 600. As another example,controller 516′ may direct transceiver 528 to transmit interrogationcommands such as requests for the actual value of stimulationparameter(s), battery voltage, data logged at IPG 300′, and IPG 300′status data, to IPG 300′ responsive to user input received at userinterface 522′ and/or software-based programming system 600, and toreceive responses to the interrogation commands from IPG 300′. As yetanother example, controller 516′ may direct transceiver 528 to transmitcommands to IPG 300′ to calculate the impedance of electrode lead 200using a routine stored on controller 318′ of IPG 300′ and to receive thecalculated lead impedance from transceiver 332 of IPG 300′.

Transceiver 528 also may include a low power mode of operation, suchthat it periodically awakens to listen for incoming messages andresponds only to those messages including the unique device identifierassigned to that external programmer. In addition, transceiver 528 mayemploy an encryption routine to ensure that messages sent from, orreceived by, external programmer 500′ cannot be intercepted or forged.

Referring now to FIG. 6, the software implementing programming system600 is now described. The software of programming system 600 comprises anumber of functional blocks, schematically depicted in FIG. 6, includingmain block 602, event logging block 604, data download block 606,configuration setup block 608, user interface block 610, alarm detectionblock 612, sensor calibration block 614, firmware upgrade block 616,device identifier block 618, and status information block 620. Thesoftware preferably is written in C++ and employs an object orientedformat. In one preferred embodiment, the software is configured to runon top of a Microsoft Windows™ (a registered trademark of MicrosoftCorporation, Redmond, Wash.) or Unix-based operating system, such as areconventionally employed on desktop and laptop computers. The computerrunning programming system 600 preferably includes a data port, e.g.,USB port or comparable wireless connection, that permits externalprogrammer 500 and/or activator 400 to be coupled thereto.Alternatively, as discussed above, the computer may include a wirelesscard, e.g., conforming to the IEEE 802.11 standard, thereby enabling IPG300, activator 400, and/or external programmer 500 to communicatewirelessly with the computer running programming system 600. As afurther alternative, IPG 300, activator 400, and/or external programmer500 may include a communications circuit(s) having telephony circuitry,e.g., GSM, CDMA, LTE circuitry, or the like, that automatically dialsand uploads data, such as alarm data, from IPG 300 to a secure websiteaccessible by the patient's physician.

Main block 602 preferably includes a main software routine that executeson the physician's computer, and controls overall operation of the otherfunctional blocks. Main block 602 enables the physician to downloadevent data and alarm information stored on IPG 300, via externalprogrammer 500, to his office computer, and also permits programmingsystem 600 to directly control operation of IPG 300, via externalprogrammer 500. Main block also enables the physician to upload firmwareupdates and configuration data to IPG 300 via external programmer 500.

Event Log block 604 is a record of operational data downloaded from IPG300, using external programmer 500, and may include, for example,treatment session start and stop times, current stimulation parameters,stimulation parameters from previous treatment sessions, sensor data,lead impedance, battery current, battery voltage, battery status, andthe like. The event log also may include the occurrence of events, suchas alarms or other abnormal conditions.

Data Download block 606 is a routine that commands IPG 300, usingexternal programmer 500, to transfer data to programming system 600 fordownload after IPG 300 is coupled to the computer programming system 600via external programmer 500. Data Download block 606 may initiate,either automatically or at the instigation of the physician via userinterface block 610, downloading of data stored in the event log.

Configuration Setup block 608 is a routine that configures theparameters stored within IPG 300, using external programmer 500, thatcontrol operation of IPG 300. The interval timing parameters maydetermine, e.g., how long the processor remains in sleep mode prior tobeing awakened to listen for radio communications or to control IPG 300operation. The interval timing parameters may control, for example, theduration of a treatment session. Interval timing settings transmitted toIPG 300 from programming system 600 also may determine when and howoften event data is written to the memory in controller 318. In anembodiment in which external programmer 500 is also configured totransfer data to activator 400, programming system 600 also may be usedto configure timing parameters used by the firmware executed bycontroller 426 of activator 400. Block 608 also may be used by thephysician to configure parameters stored within the memory of controller318 relating to limit values on operation of controller 318. Thesevalues may include times when IPG 300 may and may not operate, etc.Block 608 also may configure parameters store within the memory ofcontroller 318 relating to control of operation of IPG 300. These valuesmay include target numbers of treatment sessions and stimulationparameters.

User interface block 610 handles display of information retrieved fromthe programming system 600 and IPG 300, via external programmer 500, anddata download block 606, and presents that information in an intuitive,easily understood format for physician review. Such information mayinclude status of IPG 300, treatment session start and stop times,current stimulation parameters, stimulation parameters from previoustreatment sessions, sensor data, lead impedance, battery status, and thelike. User interface block 610 also generates user interface screensthat permit the physician to input information to configure the sessiontiming, stimulation parameters, requests to calculate lead impedance,etc.

Alarm detection block 612 may include a routine for evaluating the dataretrieved from IPG 300, using external programmer 500, and flaggingabnormal conditions for the physician's attention. For example, alarmdetection block 612 may flag when a parameter measured by system sensors328 is above or below a predetermined threshold.

Sensor calibration block 614 may include a routines for testing ormeasuring drift, of system sensors 328 employed in IPG 300, e.g., due toaging or change in humidity. Block 614 may then compute offset valuesfor correcting measured data from the sensors, and transmit thatinformation to IPG 300 for storage in the nonvolatile memory ofcontroller 318.

Firmware upgrade block 616 may comprise a routine for checking theversion numbers of the controller firmware installed on IPG 300, usingexternal programmer 500, and identify whether upgraded firmware exists.If so, the routine may notify the physician and permit the physician todownload revised firmware to IPG 300, in nonvolatile memory.

Device identifier block 618 consists of a unique identifier for IPG 300that is stored in the nonvolatile memory of controller 318 and a routinefor reading that data when programming system 600 is coupled to IPG 300via external programmer 500. The device identifier also may be used byIPG 300 to confirm that wireless communications received from activator400 and/or external programmer 500 are intended for that specific IPG.Likewise, this information is employed by activator 400 and/or externalprogrammer 500 to determine whether a received message was generated bythe IPG associated with that system. Finally, the device identifierinformation may be employed by programming system 600 to confirm thatactivator 400 and IPG constitute a matched set.

Status information block 620 comprises a routine for interrogating IPG300, when connected via activator 400, or external programmer 500 andprogramming system 600, to retrieve current status data from IPG 300,using external programmer 500. Such information may include, forexample, battery status, stimulation parameters, lead impedance, thedate and time on the internal clocks of treatment sessions, versioncontrol information for the firmware and hardware currently in use, andsensor data.

Referring now to FIGS. 7A to 7D, an exemplary method for implanting anelectrode lead and IPG is described. First, electrode lead 200, IPG 300,stylet (not shown), suture sleeve 700, introducer 702, and dilator 704are provided, as shown in FIG. 7A. In FIG. 7A, components of the systemare not depicted to scale on either a relative or absolute basis. Suturesleeve 700 illustratively includes first end section 706, middle section708 separated from first end section by first groove 710, second endsection 712 separated from middle section 708 by second groove 714, andsleeve lumen 716. First and second end sections 706 and 712 may havetruncated conical portions as shown. First and second grooves 710 and714 are sized and shaped to accept sutures such that suture sleeve 700may be secured to tissue, e.g., superficial fascia, using the sutures.Sleeve lumen 716 is sized such that electrode lead 200 may be insertedtherethrough.

Introducer 702 may include introducer lumen 718, distal tip 720, andcoupling portion 722. Introducer lumen 718 extends through introducer702 and is shaped and sized to permit electrode lead 200 to slidetherethrough. Distal tip 720 is beveled to ease introduction throughtissue. Coupling portion 722, illustratively a female end with threads,is configured to be coupled to a portion of dilator 704. In oneembodiment, introducer 702 comprises a commercially available 7 French(Fr) introducer.

Dilator 704 may include dilator lumen 724, distal tip 726, couplingportion 728, and handle 730. Dilator lumen 724 extends through dilator704 and is shaped and sized to permit introducer 702 to slidetherethrough. Distal tip 726 is beveled to ease introduction throughtissue. Coupling portion 728, illustratively a male end with threads, isconfigured to be coupled to a portion of introducer 702, e.g., couplingportion 722. Handle 730 is sized and shaped to permit a physician tocomfortably hold dilator 704.

Next, a stylet is inserted within the stylet lumen of electrode lead 200to provide additional stiffness to electrode lead 200 to ease passage ofelectrode lead 200 through introducer 702. The stylet may be acommercially available stylet such as a locking stylet available fromCook Group Incorporated of Bloomington, Ind. Electrode lead 200 then isinserted within introducer lumen 718 of introducer 702.

Using fluoroscopy, acoustic, anatomic, or CT guidance, dilator 704 isdelivered transcutaneously and transmuscularly to a target site, e.g.,in or adjacent to tissue associated with control of the lumbar spine.Such tissue may include nervous tissue, muscle, ligament, and/or jointcapsule. In one embodiment, muscle includes skeletal muscle such as themultifidus, transverse abdominus, quadratus lumborum, psoas major,internus abdominus, obliquus externus abdominus, and erector spinaemuscles and nervous tissue includes a peripheral nerve that innervatesskeletal muscle. In a preferred embodiment, nervous tissue comprises thedorsal ramus nerve, or fascicles thereof, that innervate the multifidusmuscle.

Next, introducer 702 (having a portion of the electrode lead disposedtherein) is inserted through dilator lumen 724 to the target site.Introducer 702 may then be coupled to dilator 704, e.g., by screwingcoupling portion 722 onto coupling portion 728.

FIGS. 7B-7D depict a lateral projection of a segment of a typical humanlumbar spine shown having a vertebral body V, transverse process TP,intertransversarii ITV, a dorsal ramus DR, and a dorsal root ganglionDRG. In FIG. 7B, dilator 704 having introducer 702 disposedtherethrough, which has a portion of the electrode lead disposedtherein, are positioned adjacent to the target site, illustratively, themedial branch of the dorsal ramus DR nerve that innervates themultifidus muscle. In one embodiment, electrodes of the electrode leadare positioned to stimulate the medial branch of the dorsal ramus thatexits between the L2 and L3 lumbar segments and passes over thetransverse process of the L3 vertebra, thereby eliciting contraction offascicles of the lumbar multifidus at the L3, L4, L5 and Si segments andin some patients also at the L2 segment.

Introducer 702 and dilator 704 are moved proximally, e.g., using handle730, while maintaining the position of electrode lead 200 at the targetsite, as shown in FIG. 7C. The first and second fixation elements ofelectrode lead 200 individually transition from a collapsed state withinintroducer 702 to an expanded state, shown in FIG. 7C, as introducer 702passes over the respective fixation element. The first and secondfixation elements sandwich an anchor site, e.g., muscle such as theintertransversarii, therebetween without damaging the anchor site in theexpanded state to fix electrode lead 200 at the target site.

Introducer 702 and dilator 704 are moved proximally off the proximal endof electrode lead 200 and suture sleeve 700 is placed over the proximalend of electrode lead 200 and moved distally, as illustrated in FIG. 7D.When suture sleeve 700 is positioned adjacent to the superficial fasciaSF beneath skin SK, sutures are sewn into the first and second groovesof suture sleeve 700 so as to secure suture sleeve 700 to thesuperficial fascia SF.

As shown in FIG. 7D, electrode lead 200 may include strain reliefportion 250 as described below. Strain relief portion 250 is configuredto reduce lead dislodgement and/or fracture after implantation due to,for example, the lack of suitable anchor sites for the electrode leads,the torsional and/or bending stresses imposed on the electrode leads bymovement of the surrounding muscles. As described below, strain reliefportion 250 may take on a variety of structures that are designed toreduce the strain on electrode lead 200 and the fixation elements,thereby reducing the risk of lead dislodgement, fatigue fracture, andinjury to the nervous tissue through which electrode lead 200 passes. Inthe embodiment of FIG. 7D, strain relief portion 250 comprises a loop.Preferably, the loop comprises a diameter of at least 2 cm. In analternative embodiment, strain relief portion 250 comprises a “C” shape.Other strain relief structures designed to reduce the strain onelectrode lead 200 and the fixation elements of the present inventionmay be used, such as those described in U.S. Patent Application Pub. No.2014/0350653 to Shiroff, assigned to the assignee of the presentinvention, the entire contents of which are incorporated herein byreference. Strain relief portion 250 permits extension of electrode lead200 between proximal end 224 and distal end 211 of electrode lead 200without imposing excessive loads on the fixation elements that couldresult in axial displacement of the electrodes.

Finally, the IPG is coupled to the proximal end of electrode lead 200and implanted within the lower back of the patient, as described in moredetail below.

Referring now to FIGS. 7E-7G, an exemplary method for implantingelectrode lead 200′″ of FIG. 2E is described. FIGS. 7E-7G depict alateral projection of a segment of a typical human lumbar spine shownhaving a vertebral body V, transverse process TP, intertransversariiITV, dorsal root ganglion DRG, and a dorsal ramus DR. The methodillustrated in FIGS. 7E-7G uses tools constructed similarly to thoseused in the method illustrated in FIGS. 7B-7D above, wherein likecomponents are identified by like-primed reference numbers. Thus, forexample, dilator 704′ in FIGS. 7E-7F corresponds to dilator 704 of FIGS.7B-7C, etc. In FIG. 7E, dilator 704′ having introducer 702′ disposedtherethrough, which has a portion of the electrode lead disposedtherein, are positioned adjacent to the first target site, e.g., thenervous tissue associated with the dorsal root ganglion DRG.

Introducer 702′ and dilator 704′ are moved proximally, e.g., usinghandle 730′ (not shown), while maintaining the position of electrodelead 200′″, to expose the second subset of electrodes at the firsttarget site, illustratively, the nervous tissue associated with thedorsal root ganglion, as shown in FIG. 7F. The first and second fixationelements of the electrode lead individually transition from a collapsedstate within introducer 702′ to an expanded state, shown in FIG. 7F, asintroducer 702′ passes over the respective fixation element. The firstand second fixation elements sandwich an anchor site, e.g., muscle suchas the intertransversarii ITV or nervous tissue, therebetween withoutdamaging the anchor site in the expanded state to fix the second subsetof electrodes at the first target site. Introducer 702′ and dilator 704′are further moved proximally, e.g., using handle 730′, while maintainingthe position of the second subset of electrodes at the first target sitewith the assistance of the first and second fixation elements, to exposethe first subset of electrodes at the second target site,illustratively, the medial branch of the dorsal ramus DR nerve orfascicles thereof that innervates the multifidus muscle. For example,the first subset of electrodes of electrode lead 200′″ at the secondtarget site may be positioned to stimulate the medial branch of thedorsal ramus DR nerve or fascicles thereof that exits between the L2 andL3 lumbar segments and passes over the transverse process of the L3vertebra, thereby eliciting contraction of fascicles of the lumbarmultifidus at the L3, L4, L5 and Si segments and in some patients alsoat the L2 segment.

Introducer 702′ and dilator 704′ are moved proximally off the proximalend of electrode lead 200′″ and suture sleeve 700′ may be placed overthe proximal end of electrode lead 200′″ and moved distally, asillustrated in FIG. 7G. When suture sleeve 700′ is positioned adjacentto the superficial fascia SF beneath skin SK, sutures are sewn into thefirst and second grooves of suture sleeve 700′ so as to secure suturesleeve 700′ to the superficial fascia SF. Electrode lead 200′″ maycomprise strain relief portion 250′ similar to strain relief portion 250of electrode lead 200 of FIG. 7D described above to reduce axial strainon the fixation elements at the anchor site. Illustratively, strainrelief portion 250′ is a loop in electrode lead 200′″ proximal to theelectrodes on the lead and distal to the suture sleeve 700′.

Referring now to FIG. 7H, multiple electrode leads may be implantedusing the methods described above. For example, electrode leads 207 and209 may be structurally similar to any of the electrode leads of FIGS.2A through 2G described above, and may contain a plurality of electrodesdisposed at their respective distal ends. The plurality of electrodesare configured to be implanted in or adjacent to tissue at the opposingside of the spine, such as nervous tissue, muscle, ligament, and/orjoint capsule. For example, after implanting a first electrode lead asdescribed in FIGS. 7B through 7D or FIGS. 7E through 7G, the respectiveimplantation method may be repeated on the opposing side of the spine toimplant a second electrode lead. Electrode leads 207 and 209 may includefixation elements at their respective distal ends configured to anchorelectrode leads 207 and 209 to their respective anchor sites. Asillustrated in FIG. 7H, electrode lead 207 may be anchored at adifferent anchor site to electrode lead 209. For example, electrode lead207 may be anchored to a first anchor site, e.g., muscle such as theintertransversarii on one side of the spine, such that the plurality ofelectrodes disposed thereon are in or adjacent to the dorsal rootganglion and/or the medial branch of the dorsal ramus nerve or fasciclesthereof that innervates the multifidus muscle located on one side of thelumbar spine while electrode lead 209 may be anchored to a second anchorsite, e.g., muscle such as the intertransversarii on the opposing sideof the spine, such that the plurality of electrodes disposed thereon arein or adjacent to the dorsal root ganglion and/or to the medial branchof the dorsal ramus nerve or fascicles thereof that innervates themultifidus muscle located on the opposite side of the lumbar spine.

Referring now to FIG. 7I, an exemplary tunneler system for tunneling theproximal end of an electrode lead subcutaneously for coupling to an IPGis described. First, tunneler system 740 is provided. Tunneler system740 may include tunneler 742, bullet-shaped tunneler tip 744 and/orfacet-shaped tunneler tip 746, sheath 748, and optionally back-up sheath750. Tunneler 742 includes an elongated shaft with handle 752 at theproximal end and distal portion 754 configured for coupling, e.g., viathreads, to the selected tunneler tip. Bullet-shaped tunneler tip 744and facet-shaped tunneler tip 746 may include mating threaded portionsconfigured to be coupled to threaded distal portion 754 of tunneler 742.Both bullet-shaped tunneler tip 744 and facet-shaped tunneler tip 746are configured to create a subcutaneous passage to accept sheath 748. Aclinician selects a desired bullet-shaped tunneler tip 744 orfacet-shaped tunneler tip 746 to use based on application and userpreference. Sheath 748 includes an inner lumen for receiving theelongated shaft of tunneler 742 and may be shaped and sized to fitbetween stopper 756 adjacent to handle 752 and threaded distal portion754 of tunneler 742. The outer diameter of sheath 748 may beapproximately the same as the maximum outer diameter of bullet-shapedtunneler tip 744 and facet-shaped tunneler tip 746. In addition, sheath748 is configured to be disposed temporarily in the subcutaneous passagecreated by either bullet-shaped tunneler tip 744 or facet-shapedtunneler tip 746. FIG. 7J shows select components of the tunneler systemof FIG. 7I in an assembled state.

As described above, a clinician may make a first incision and implantthe distal end of electrode lead 200 in accordance with the methoddescribed in FIGS. 7B-D, or alternatively, may make a first incision andimplant the distal end of electrode lead 200′″ in accordance with themethod described in FIGS. 7E-G.

FIG. 7K is a flow chart showing exemplary method 760 for tunnelingbetween a first incision, where the distal end of an electrode lead isimplanted, to a second incision, where an IPG is within the incision oroutside the incision, such that the proximal end of the electrode leadmay be coupled to the IPG and the electrode lead and IPG may be fullyimplanted. At 762, the clinician makes the second incision at a locationremote from the location of the first incision, e.g., about 4-5 inchesaway from the first incision, to implant the IPG. The assembled tunnelersystem as shown in FIG. 7J is used to subcutaneously tunnel from thesecond incision to the first incision, or vice versa, to permit theproximal end of the electrode lead to be positioned through sheath 748adjacent to the IPG for coupling. For example, once the distal end ofthe electrode lead is implanted and the proximal end is exposed at thefirst incision site, the clinician selects the partially assembled orassembled tunneler system as such shown in FIG. 7J, or if unassembled,slides sheath 748 over the elongated shaft of tunneler 742, and installsthe desired bullet-shaped tunneler tip 744 or facet-shaped tunneler tip746 to the threaded distal portion of tunneler 742.

At 764, the clinician inserts tunneler 742 and sheath 748 into thesecond incision and at 766, advances tunneler system 740 subcutaneouslyuntil the selected desired tunneler tip reaches the first incision site,so that tunneler 742 and sheath 748 span the first and second incisionsites. Alternatively, the clinician could tunnel from the first incisionsite to the second incision site.

At 768, the clinician removes the selected desired tunneler tip and at770, withdraws tunneler 742 from sheath 748 through the second incisionsite while holding the distal end of sheath 748 at the first incisionsite. In this manner, one end of sheath 748 is exposed at one incisionand the other end of sheath 748 is exposed at the other incision whileportions of sheath 748 remain beneath the skin. At 772, the clinicianthen feeds the proximal end of the electrode lead into the distal end ofsheath 748 until it reaches the second incision site. At 774 theclinician pulls sheath 748 out through the second incision site suchthat the proximal end of the electrode lead remains exposed at thesecond incision site. At 776, the clinician connects the proximal end ofthe electrode lead to the IPG, inside or outside the body and at 778,closes the second incision with the IPG therein. The first incision isclosed as well before or after the second incision is closed. As aresult, the electrode lead and the IPG are fully implanted.

Exemplary stimulation parameters in accordance with aspects of thepresent invention are now described. Preferably, such stimulationparameters are selected and programmed to induce contraction of muscleto restore neural control and rehabilitate muscle associated withcontrol of the spine, thereby improving lumbar spine stability andreducing back pain. As used in this specification, “to restore musclefunction” means to restore an observable degree of muscle function asrecognized by existing measures of patient assessment, such as theOswestry Disability Index (“ODI”) as described in Lauridsen et al.,Responsiveness and minimal clinically important difference for pain anddisability instruments in low back pain patients, BMC MusculoskeletalDisorders, 7: 82-97 (2006), the European Quality of Life Assessment 5D(“EQ-5D”) as described in Brazier et al., A comparison of the EQ-5D andSF-6D across seven patient groups, Health Econ. 13: 873-884 (2004), or aVisual Analogue Scale (“VAS”) as described in Hagg et al., The clinicalimportance of changes in outcome scores after treatment for chronic lowback pain, Eur Spine J 12: 12-20 (2003). In accordance with one aspectof the present invention, “to restore muscle function” means to observeat least a 15% improvement in one of the foregoing assessment scoreswithin 30-60 days of initiation of treatment. As described above, thestimulation parameters may be programmed into the IPG, may be adjustedin the IPG responsive to (i) stimulation commands transferred from theactivator or (ii) programming data transferred from the externalprogrammer.

The stimulation parameters include, for example, pulse amplitude(voltage or current), pulse width, stimulation rate, stimulationfrequency, ramp timing, cycle timing, session timing, and electrodeconfiguration, including commands to start or stop a treatment session.In one embodiment, pulse amplitude is programmed to be adjustablebetween 0 and 7 mA. In a preferred embodiment, pulse amplitude isprogrammed to be between about 2-5 mA, 2.5-4.5 mA, or 3-4 mA, andpreferably about 3.5 mA. In one embodiment, pulse width is programmed tobe adjustable between 25 and 500 μs. In a preferred embodiment, pulsewidth is programmed to be between about 100-400 μs, 150-350 μs, or200-300 μs, and preferably about 350 Vs. In one embodiment, stimulationrate is programmed to be adjustable between 1 and 40 Hz. In a preferredembodiment, stimulation rate is programmed to be between about 5-35 Hz,10-30 Hz, or 15-20 Hz, and preferably about 20 Hz. In one embodiment, onramp timing is programmed to be adjustable between 0 and 5 s. In apreferred embodiment, on ramp timing is programmed to be between about0.5-4.5 s, 1-4 s, 1.5-3.5 s, or 2-3 s, and preferably about 2.5 s. Inone embodiment, off ramp timing is programmed to be adjustable between 0and 5 s. In a preferred embodiment, off ramp timing is programmed to bebetween about 0.5-4.5 s, 1-4 s, 1.5-3.5 s, or 2-3 s, and preferablyabout 2.5 s. In one embodiment, cycle-on timing is programmed to beadjustable between 2 and 20 s. In a preferred embodiment, cycle-ontiming is programmed to be between about 4-18 s, 6-16 s, 8-14 s, 9-13 s,or 10-12 s and preferably about 10 s. In one embodiment, cycle-offtiming is programmed to be adjustable between 20 and 120 s. In apreferred embodiment, cycle-off timing is programmed to be between about30-110 s, 40-100 s, 50-90 s, 55-85 s, 60-80 s, or 65-75 s and preferablyabout 70 s. In one embodiment, session timing is programmed to beadjustable between 1 and 60 min. In a preferred embodiment, sessiontiming is programmed to be between about 5-55 min, 10-50 min, 15-45 min,20-40 min, or 25-35 min, and preferably about 30 min.

In another embodiment, the first subset of electrodes are configured tostimulate the target tissue according to stimulation parameters that aredifferent from the stimulation parameters by which the second subset ofelectrodes are configured to stimulate the respective target tissue. Forexample, the subset of electrodes located in or adjacent to the nervoustissue associated with the dorsal root ganglion may be configured tostimulate the target tissue according to stimulation parametersdifferent from the stimulation parameters used by the other subset ofelectrodes to stimulate the medial branch of the dorsal ramus nerve thatinnervates the multifidus muscle. In one embodiment, pulse amplitude isprogrammed to be adjustable between 0 to 2000 μA. In a preferredembodiment, pulse amplitude is programmed to be between 0 and 1000 μA.In one embodiment, pulse width is programmed to be adjustable between 40and 300 ms. In a preferred embodiment, pulse width is programmed to bebetween about 40-300 ms, 200 ms, or 300 ms, and preferably about 200-300ms. In one embodiment, stimulation frequency is programmed to be atleast 16 Hz. In a preferred embodiment, stimulation rate is programmedto be between 16-100 Hz, 20 Hz, 30, Hz, 40 Hz, 50 Hz, 20-50 Hz, 20-30Hz, 20-40 Hz, 30-40 Hz, 30-50 Hz, or preferably between 40-50 Hz.

FIG. 8 is a graph of an exemplary charge-balanced electrical stimulationwaveform that may be delivered by the electrodes and IPG of the presentinvention. The IPG directs the electrodes, responsive to programming,stimulation commands, and/or received programming data, to stimulate ata pulse amplitude for the time of a pulse width and then balances thecharge by dropping to a negative pulse amplitude and then bringing thepulse amplitude back to zero over the time of a waveform. Thestimulation may be current-controlled and charge-balanced, orvoltage-controlled and charge-balanced.

FIG. 9 is a graph showing an exemplary stimulation pulse train that maybe delivered by the electrodes and IPG of the present invention. Duringcycle-on programming, the IPG directs the electrodes, responsive toprogramming, stimulation commands, and/or received programming data, todeliver a stimulation pulse train in an “on ramp” manner such that thepulse amplitude increases in predetermined increments to reach theprogrammed peak pulse amplitude. In this way, the number of pulses inthe “on ramp” needed to reach the programmed peak pulse amplitude may bedetermined by the IPG responsive to data supplied by the programmingsystem. After reaching the programmed peak pulse amplitude, the IPGdirects the electrodes to deliver at the programmed peak pulse amplitudefor a predetermined number of stimulation pulses. After thepredetermined number of stimulation pulses is reached, the IPG directsthe electrodes, responsive to programming, stimulation commands, and/orreceived programming data, to deliver a stimulation pulse train in an“off ramp” manner such that the pulse amplitude decreases inpredetermined increments from the programmed peak pulse amplitude tozero. As shown in FIG. 9, the pulse amplitude may drop, e.g., to zero,between each stimulation pulse.

FIG. 10 is a graph showing an exemplary session that may be delivered bythe electrodes and IPG of the present invention. In this example, duringa cycle, the IPG directs the electrodes, responsive to programming,stimulation commands, and/or received programming data, to deliverelectrical stimulation for the cycle-on duration, followed by acycle-off duration of no electrical stimulation. Illustratively, asession is a programmable duration of repetitive cycles and the sessiondelay is the time delay between the receipt of the command by the IPG tostart a session to the start of the first cycle. After a session iscompleted, IPG directs the electrodes, responsive to programming,stimulation commands, and/or received programming data, to stopdelivering electrical stimulation until a new session begins.

Referring now to FIGS. 11-15, exemplary screen shots generated by userinterface block 610 of software 600 are described for a stimulatorsystem. FIG. 11 shows main program screen 1100 that is displayed to aphysician running software-based programming system 600. Main programscreen 1100 includes identification and status area 1102, electrodeconfiguration area 1104, session parameters area 1106, impedance loggingarea 1108, settings area 1110, and buttons 1112.

In FIG. 11, identification and status area 1102 includes Subject ID, IPGMode, Battery Status, Serial No., and Magnet Effect. Subject ID permitsa user, e.g., a physician, to enter an ID, which is then displayed, fora subject having implanted electrodes and an IPG of the presentinvention. IPG Mode permits a user to turn the mode “ON”, such that theIPG implanted in the subject is activated, and turn the mode “OFF”, suchthat the IPG is deactivated. Battery Status displays the remainingbattery power of the power supply in the IPG. Battery Status may beupdated after a user interrogates the IPG to request updated batterystatus information. Serial No. displays the serial number assigned tothe IPG implanted in the subject. Magnet Effect permits a user changehow the IPG responds to sensing a magnetic field from a magnet, e.g.,magnet 450. For example, a user may select “Stop Session Only”, suchthat the IPG will only stop a stimulation session upon sensing themagnet; the user may select “Start Session Only”, such that the IPG willonly start a stimulation session upon sensing the magnet; the user mayselect “Start and Stop Session”, such that the IPG will interchangeablystop or stop a stimulation session each time the magnet is sensed; orthe user may select “No Effect”, such that the IPG does not respond tosensing the magnet.

Electrode configuration area 1104 includes Stimulation Mode, Rate, rightelectrode lead display, left electrode lead display, Amplitude, PulseWidth, Impedance area, and Offset. Stimulation Mode permits a user toselect a “Bilateral” mode where electrodes on two separate electrodeleads stimulate tissue at the same time or a “Unilateral” mode whereelectrodes on only one electrode lead stimulate tissue. Rate permits auser to select a stimulation rate of any integer between, e.g., 1-40 Hz.Right electrode lead display shows an illustration of four electrodes(numbered 1-4) on the right electrode lead implanted within the subjectwhile left electrode lead display shows the four electrodes (numbered5-8) on the left electrode lead implanted within the subject. A user mayselect which electrode(s) stimulate in a session and may change thepolarity of each electrode between positive and negative. In theillustrated embodiment, when a session begins, negative electrode 2 onthe right lead and negative electrode 6 on the left lead transmit energyto target tissue to stimulate the tissue and positive electrodes 1 and5, respectively, receive the energy after it has passed through thetarget tissue. Amplitude permits a user to adjust the pulse amplitudedelivered by an electrode on a lead. A user may increase the pulseamplitude by selecting the Amplitude button and then pressing thecorresponding up arrow button and decrease by pressing the correspondingdown arrow button for the right or the left electrode lead. In oneembodiment, the pulse amplitude increases or decreases by 0.1 mA whenthe corresponding arrow button is pressed by a user. Alternatively, auser may enter in the desired pulse amplitude using, for example, thekeyboard on the computer. Pulse Width permits a user to adjust the pulsewidth delivered by an electrode on a lead. A user may increase the pulsewidth by selecting the Pulse Width button and then pressing thecorresponding up arrow button and decrease by pressing the correspondingdown arrow button for the right or the left electrode lead. In oneembodiment, the pulse width increases or decreases by 1 is when thecorresponding arrow button is pressed by a user. Alternatively, a usermay enter in the desired pulse width using, for example, the keyboard onthe computer. Impedance area permits a user to select the MeasureImpedance button which causes the programming system, via the externalprogrammer, to command the IPG to run the routine to measure impedancesand then transmit the measured impedances back to the programmingsystem, via the external programmer. The measured impedances then aredisplayed for each electrode. Offset permits a user to offset thestimulation timing between the right and left electrodes.

Session parameters area 1106 includes Session, Cycle On, Cycle Off, OnRamp, and Off Ramp. The corresponding button for each of the parameterspermits a user to adjust the timing for each parameter by selecting thebutton and then pressing the up or down arrows, or, alternatively, byselecting the corresponding button and entering the desired parameterusing, for example, the keyboard on the computer.

Impedance logging area 1108 includes Log Impedance Daily, Daily LogTime, Log Impedance Matrix, and Matrix Log Period. Log Impedance Dailyincludes a button that permits a user to select “YES” or “NO”. If a userselects “YES”, the IPG will run the impedance test routine every day andstore the measured impedance in its memory for transfer to theprogramming system software. Daily Log Time permits a user to adjust howmany hours and minutes per day the IPG will log the measured impedance.Log Impedance Matrix permits a user to select “YES”, where the IPG willstore the measured impedance in matrix form, and “NO” where the IPG willnot store the measured impedance in matrix form. Matrix Log Periodpermits a user to select “Hourly”, “Daily”, or “Weekly”, whereby the IPGwill store the measured impedance in a matrix every hour, every day, orevery week, respectively.

Settings area 1110 includes Cumulative Max, Lockout Time, Session Delay,Pulse Train Balance, Interphase Period, Balance Mode, Voltage Limit, andTranspose L-R. Cumulative Max permits a user to select the maximumcumulative stimulation session minutes in an amount of days. LockoutTime permits a user to set a number of hours or minutes that astimulation session may not be initiated. Session Delay permits a userto select a number of seconds that a session will be delayed after IPGreceives a command to start a session. Pulse Train Balance permits auser to cause a pulse train balance mode to be “Enabled” or “Disabled”.The pulse train balance mode may be the mode described above withrespect to FIG. 9. Interphase Period permits a user to adjust the timebetween stimulation pulses. Balance Mode permits a user to cause abalance mode to be “Active” or “Inactive”. The balance mode may be themode described above with respect to FIG. 8. Voltage Limit permits auser to adjust the maximum voltage that may be supplied from the powersource to the electrodes. In one embodiment, Voltage Limit may be set to“Automatic” such that the controller of the IPG determines the maximumvoltage based on predetermined thresholds programmed therein. TransposeL-R permits a user to turn “ON” or “OFF” a mode that, when activated,causes stimulation to be interchanged between the electrodes on theright electrode lead and the electrodes on the left electrode lead.

Buttons 1112 include Interrogate, Program, Start Session, and StopSession. When pressed, the “Interrogate” button causes thecommunications circuitry in the external programmer to transmitinterrogation commands, such as requests for the (i) actual value ofstimulation parameter(s) programmed in the IPG, (ii) battery voltageremaining in the IPG, (iii) data logged in the IPG, and (iv) IPG statusdata, to the communications circuitry in the IPG for processing by theIPG controller. The responsive data is then sent back to the software,via communications circuitry in the IPG and external programmer, fordisplay on the user interface of the computer, such as main programscreen 1100. The “Program” button, when pressed, causes thecommunications circuitry in the external programmer to transmitprogramming data to the communications circuitry in the IPG forprocessing by the IPG controller. Programming data may include, forexample, adjustments made by the user to the various input areas in mainprogram screen 1100. The “Start Session” button, when pressed, causesthe communications circuitry in the external programmer to transmit acommand to begin a treatment session, or optionally programming datathat includes such a command, to the communications circuitry in the IPGat the selected stimulation parameters for processing by the IPGcontroller. The stimulation parameter data may be stored in the IPGcontroller such that future sessions will cause stimulation at theselected stimulation parameters. The “Stop Session” button, whenpressed, causes the communications circuitry in the external programmerto transmit a command to stop a treatment session to the communicationscircuitry in the IPG for processing by the IPG controller.

FIG. 12 shows temporary program screen 1200 that is displayed to aphysician running software-based programming system 600. Temporaryprogram screen 1200 includes electrode configuration area 1202, sessionparameters area 1204, settings area 1206, and buttons 1208. Temporaryprogram screen 1200 permits a user to adjust stimulation parameters on atemporary basis, e.g., for one or two sessions.

Electrode configuration area 1202 is similar to electrode configurationarea 1104 of FIG. 11 and for conciseness, will not be described again indetail. Session parameters area 1204 is similar to session parametersarea 1106 of FIG. 11, although session parameters area 1204 may includefewer parameters for user adjustment. Illustratively, session parametersarea 1204 includes On Ramp and Off Ramp.

Settings area 1206 is similar to settings area 1110 of FIG. 11, althoughsettings area 1206 may include fewer settings for user adjustment.Illustratively, settings area 1206 includes Pulse Train Balance,Interphase Period, Balance Mode, Voltage Limit, and Transpose L-R.

Buttons 1208 include Start Temporary Program, Stop Temporary Program,and Copy Changed Values to Main Screen. The “Start Temporary Program”button, when pressed, causes the communications circuitry in theexternal programmer to transmit a command to begin a treatment sessionto the communications circuitry in the IPG at the selected temporarystimulation parameters for processing by the IPG controller. Thetemporary stimulation parameter data may be stored in the IPG controlleron a temporary basis such that future sessions will cause stimulation atthe stimulation parameters programmed prior to receipt of the temporarystimulation parameters. The “Stop Temporary Program” button, whenpressed, causes the communications circuitry in the external programmerto transmit a command to stop a treatment session to the communicationscircuitry in the IPG for processing by the IPG controller. The “CopyChanged Values to Main Screen” button, when pressed, causessoftware-based programming system 600 to copy the temporary stimulationparameters entered in screen 1200 into corresponding input areas in mainprogram screen 1100 of FIG. 11.

FIG. 13 shows impedance screen 1300 that is displayed to a physicianrunning software-based programming system 600. Impedance screen 1300includes electrode configuration area 1302 and impedance matrix area1304.

Electrode configuration area 1302 includes right electrode leadimpedance display, left electrode lead impedance display, and Impedancearea. Right electrode lead impedance display shows an illustration offour electrodes (numbered 5-8) on the right electrode lead implantedwithin the subject while left electrode lead impedance display shows thefour electrodes (numbered 1-4) on the left electrode lead implantedwithin the subject. A user may select at which electrode(s) to measureimpedance using the respective displays. Impedance area permits a userto select the “Measure Impedance” button which causes the programmingsystem, via the external programmer, to command the IPG to run theroutine to measure impedances at the electrodes selected in the leaddisplays and then transmit the measured impedances back to theprogramming system, via the external programmer. The measured impedancesthen is displayed for each electrode. Selection of electrodes on thelead displays for measuring impedance does not affect electrodeconfiguration area 1104 of main program screen 1100 in FIG. 11.

Impedance matrix area 1304 includes an impedance matrix and a MeasureImpedance Matrix button. When pressed, the “Measure Impedance Matrix”button causes the impedance matrix to be populated with the measuredimpedances in accordance with selections made at electrode configurationarea 1302. In the illustrated embodiment, impedance between electrode 2(selected to be negative) and electrode 1 (selected to be positive) onthe left lead is measured to be 490 Ohms and impedance between electrode6 (selected to be negative) and electrode 5 (selected to be positive) onthe right electrode lead is measured to be 1355 Ohms. Thus, when theMeasure Impedance Matrix button is pressed, the software causes 490 tobe populated at the intersection of 2 negative and 1 positive and 1355to be populated at the intersection of 6 negative and 5 positive in theimpedance matrix. The impedance matrix also may display when anelectrode is excluded or out of range.

FIG. 14 shows data review screen 1400 that is displayed to a physicianrunning software-based programming system 600. Data review screen 1400includes daily log area 1402 and data matrix area 1404.

Daily log area 1402 permits a user to view, on a day-by-day basis,Number of Daily Sessions, Total Daily Session Time, Daily Impedance, andVoltage. The date button permits a user to select a day and time suchthat a user may view stored data from the selected day/time. The “Numberof Daily Sessions” area displays the number of treatment sessions thatwere started for the selected day. The “Total Daily Session Time” areadisplays the number of minutes of treatment sessions for the selectedday. The “Daily Impedance” area displays the measured impedance of theright and left electrode lead for the selected day. The “Voltage” areadisplays the measured voltage remaining in the IPG power supply at theend of the selected day.

Data matrix area 1404 includes a data matrix and a “Get Stored Data”button. When pressed, the “Get Stored Data” button, causes thecommunications circuitry in the external programmer to transmit arequest for stored data to the communications circuitry in the IPG forprocessing by the IPG controller. The IPG controller retrieves thestored data from its memory and causes the communications circuitry inthe IPG to transmit the stored data to the communications circuitry inthe external programmer for display on data review screen 1400. The datamatrix is populated with received stored data in the appropriate row andcolumn corresponding to the electrode configuration. The data matrixalso may display when an electrode is disabled.

FIG. 15 shows data graphs screen 1500 that is displayed to a physicianrunning software-based programming system 600. Data graphs screen 1500includes session time graph 1502 and impedance graph 1504. Session timegraph 1502 displays the total daily session time on a daily basis, asretrieved from stored data in the IPG. In the illustrated embodiment,session time 1506 shows that the patient used the stimulation system for60 minutes on the first day and then did not use the stimulation systemfor the next 15 days. Impedance graph 1504 displays the daily impedancefor the right and left electrode lead on a daily basis, as retrievedfrom stored data in the IPG. In the illustrated embodiment, rightimpedance 1508 shows that the measured impedance for the electrodes onthe right electrode lead was about 12,000 ohms over three days, whileleft impedance 1510 shows that the measured impedance for the electrodeson the left electrode lead was about 1400 ohms over three days. Whenpressed, the “Get Stored Data” button, causes the communicationscircuitry in the external programmer to transmit a request for storeddata to the communications circuitry in the IPG for processing by theIPG controller. The IPG controller retrieves the stored data from itsmemory and causes the communications circuitry in the IPG to transmitthe stored data to the communications circuitry in the externalprogrammer for display on data graphs screen 1500.

As will be readily understood by one of ordinary skill in the art, auser may enter data into the user interface using suitable mechanismsknown in the art, such as, entering numbers, letters, and/or symbols viaa keyboard or touch screen, mouse, touchpad, selection from a drop-downmenu, voice commands, or the like.

While various illustrative embodiments of the invention are describedabove, it will be apparent to one skilled in the art that variouschanges and modifications may be made therein without departing from theinvention. The appended claims are intended to cover all such changesand modifications that fall within the true scope of the invention.

What is claimed:
 1. A kit for use in implanting components for restoringmuscle function of the lumbar spine, the kit comprising: an electrodelead configured to be implanted in or adjacent to tissue associated withcontrol of the lumbar spine, the electrode lead having a proximal endand a distal end with one or more electrodes disposed thereon; a pulsegenerator configured to be coupled to the proximal end of the electrodelead, the pulse generator having a programmable controller configured toprovide electrical stimulation via the one or more electrodes disposedon the electrode lead; a tunneler comprising an elongated shaft, aproximal end having a handle, a stopper positioned between the elongatedshaft and the handle, and a threaded portion at a distal end of theelongated shaft; a tunneler tip having a mating portion configured to beremovably coupled to the threaded portion of the tunneler, the tunnelertip configured to create a subcutaneous passage; and a sheath having alumen extending therethrough, the lumen configured to receive thethreaded portion of the tunneler, the elongated shaft of the tunneler,and the proximal end of the electrode lead therethrough, the sheathsized and shaped to fit over the elongated shaft of the tunneler alongan entire length of the sheath such that the sheath is disposed betweenthe stopper and the threaded portion of the tunneler, the sheath furtherconfigured to be disposed temporarily in the subcutaneous passage. 2.The kit of claim 1, wherein the pulse generator is configured to beimplanted at an end of the subcutaneous passage.
 3. The kit of claim 1,wherein the programmable controller directs one or more of the at leastone or more electrodes to stimulate at least one of a dorsal ramusnerve, or fascicles thereof, that innervate a multifidus muscle ornervous tissue associated with a dorsal root ganglia nerve.
 4. The kitof claim 3, wherein the programmable controller directs the one or moreelectrodes to stimulate both the dorsal ramus nerve, or fasciclesthereof, that innervate the multifidus muscle, and the nervous tissueassociated with the dorsal root ganglia nerve simultaneously.
 5. The kitof claim 1, wherein the tunneler tip is selected from a group comprisinga bullet-shaped tunneler tip and a facet-shaped tunneler tip.
 6. The kitof claim 1, wherein an outer diameter of the sheath is equal to an outerdiameter of the tunneler tip.
 7. The kit of claim 1, further comprisinga first fixation element coupled to the electrode lead proximal to atleast one of the at least one or more electrodes, the first fixationelement configured to anchor the electrode lead to an anchor site. 8.The kit of claim 7, further comprising a second fixation element coupledto the electrode lead distal to the first fixation element, wherein thefirst fixation element is angled distally relative to the electrode leadand the second fixation element is angled proximally relative to theelectrode lead in a deployed state, and wherein the first and secondfixation elements are configured to sandwich the anchor sitetherebetween.
 9. The kit of claim 8, wherein at least one of the one ormore electrodes is disposed between the first and second fixationelements.
 10. A method for implanting components for restoring musclefunction of the lumbar spine, the method comprising: implanting a distalend of an electrode lead at a first incision site so that one or moreelectrodes disposed thereon are disposed in or adjacent to tissueassociated with control of the lumbar spine; selecting a tunnelercomprising an elongated shaft having a threaded distal portion, aproximal end having a handle, and a tunneler tip removably coupled tothe threaded distal portion; sliding the threaded distal portion througha lumen of a sheath such that the sheath is disposed on the elongatedshaft along an entire length of the sheath and is disposed between thestopper and the threaded distal portion of the tunneler; coupling thetunneler tip to the threaded distal portion of the tunneler; tunnelingthe tunneler subcutaneously between a first incision site and a secondincision site to create a subcutaneous passage therebetween such thatthe sheath spans the first and second incision sites; decoupling thetunneler tip from the threaded distal portion of the tunneler; removingthe tunneler from the sheath while the sheath continues to span thefirst and second incision sites; feeding a proximal end of the electrodelead through an end of the sheath until the proximal end of theelectrode lead is exposed at the other end of the sheath; and removingthe sheath from the subcutaneous passage between the first and secondincision sites while the electrode lead continues to span the first andsecond incision sites.
 11. The method of claim 10, wherein implantingthe distal end of the electrode lead at the first incision sitecomprises deploying a first fixation element coupled to the electrodelead proximal to at least one of the at least one or more electrodessuch that the first fixation element is angled distally relative to theelectrode lead.
 12. The method of claim 11, wherein implanting thedistal end of the electrode lead at the first incision site furthercomprises deploying a second fixation element coupled to the electrodelead distal to the first fixation element such the second fixationelement is angled proximally relative to the electrode lead so that thefirst and second fixation elements sandwich an anchor site therebetween.13. The method of claim 12, wherein the first fixation element comprisesa first plurality of projections and the second fixation elementcomprises a second plurality of projections.
 14. The method of claim 13,wherein the first plurality of projections is radially offset from thesecond plurality of projections.
 15. The method of claim 10, furthercomprising stimulating, via the one or more electrodes, the tissueassociated with control of the lumbar spine to cause muscle contraction.16. The method of claim 15, wherein stimulating the tissue comprisesstimulating a dorsal ramus nerve, or fascicles thereof, that innervate amultifidus muscle.
 17. The method of claim 10, wherein the tunneler tipis selected from a group comprising a bullet-shaped tunneler tip and afacet-shaped tunneler tip.
 18. The method of claim 10, wherein an outerdiameter of the sheath is equal to an outer diameter of the tunnelertip.
 19. The method of claim 10, further comprising coupling theproximal end of the electrode lead to a pulse generator and implantingthe pulse generator at the second incision site.
 20. The method of claim19, further comprising: selecting an external programmer and a handheldactivator; transferring programming data to the pulse generator from theexternal programmer; and operating the handheld activator to command thepulse generator to provide electrical stimulation to stimulate thetissue via the one or more electrodes responsive to the programmingdata.